Bulk Drug Substances Currently Under Review
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
Bulk Drug Substances Reviewed and Not Listed
These bulk drug substances are currently being evaluated by FDA. While these evaluations are being completed, the agency generally intends to refrain from taking enforcement action when these bulk drug substances are used to compound a finished drug in a state-licensed pharmacy or federal facility or by a state-licensed veterinarian as described in the initial nomination.
Once the evaluation for a given bulk drug substance has been fully completed, those found to meet the criteria for inclusion on a list will be removed from the “Currently Under Review” status and will be added to the appropriate list for nonfood-producing animals, food-producing animals, or free-ranging wildlife species. Those bulk drug substances that are not found to meet the criteria for inclusion on a list will be designated as “Bulk Drug Substances Reviewed and Not Listed.”
FDA will accept nominations of additional bulk drug substances at any time and will continue to review nominations and update lists. For information on how to submit a bulk drug substance nomination, see the appendix to Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.
DOGS, CATS, HORSES
NONFOOD-PRODUCING MINOR SPECIES
FOOD-PRODUCING ANIMALS (ANTIDOTES)
FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS)
DOGS, CATS, HORSES
| Bulk Drug Substance (BDS) | Species | Nomination |
|---|---|---|
| Acepromazine maleate | dog, cat, horse | FDA-2018-N-4626-0114 |
| Acetyl-D-glucosamine | dog, horse | FDA-2018-N-4626-0104 |
| Aluminum hydroxide | dog, cat | FDA-2018-N-4626-0048 |
| Amantadine | dog, horse | FDA-2018-N-4626-0136 |
| Aminocaproic acid | dog, horse | FDA-2018-N-4626-0107 |
| Aminopentamide sulfate | dog, cat | FDA-2018-N-4626-0017 |
| Aminophylline | dog, cat | FDA-2018-N-4626-0069 |
| Amitriptyline HCl | dog, cat | FDA-2018-N-4626-0018 |
| Apomorphine HCl | dog | FDA-2018-N-4626-0020 FDA-2018-N-4626-0147 |
| Atenolol | dog, cat | FDA-2018-N-4626-0041 |
| Atipamezole | horse | FDA-2018-N-4626-0054 FDA-2018-N-4626-0801 |
| Atovaquone | dog, cat | FDA-2018-N-4626-0146 |
| Atropine | horse | FDA-2018-N-4626-0752 |
| Azaperone | horse | FDA-2018-N-4626-0013 |
| Azithromycin/rifampin | dog, cat, horse | FDA-2018-N-4626-0090 |
| Benazepril HCl | dog, cat | FDA-2018-N-4626-0091 |
| Benazepril HCl/furosemide/pimobendan | dog, cat | FDA-2018-N-4626-0727 |
| Budesonide | dog, cat | FDA-2018-N-4626-0045 FDA-2018-N-4626-0725 |
| Butorphanol tartrate | dog, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Cephalexin | dog, cat | FDA-2018-N-4626-0478 |
| Cetirizine HCl | dog, cat, horse | FDA-2018-N-4626-0111 |
| Chlorambucil | dog, cat | FDA-2018-N-4626-0123 FDA-2018-N-4626-0725 |
| Chloramphenicol/betamethasone/ketoconazole | dog, cat | FDA-2018-N-4626-0552 |
| Chlorpheniramine maleate | dog, cat | FDA-2018-N-4626-0139 |
| Cidofovir | dog, cat | FDA-2018-N-4626-0032 FDA-2018-N-4626-0040 |
| Ciprofloxacin HCl | dog, cat | FDA-2018-N-4626-0652 |
| Cisapride | dog, cat, horse | FDA-2018-N-4626-0021 FDA-2018-N-4626-0655 FDA-2018-N-4626-0759 |
| Cisapride/lactulose | dog, cat | FDA-2018-N-4626-0169 |
| Cisplatin | horse | FDA-2018-N-4626-0112 |
| Clarithromycin | dog, cat, horse | FDA-2018-N-4626-0175 |
| Clarithromycin/rifampin | dog, cat, horse | FDA-2018-N-4626-0100 |
| Clindamycin HCl | dog, cat | FDA-2018-N-4626-0042 FDA-2018-N-4626-0583 |
| Cyclophosphamide | dog, cat, horse | FDA-2018-N-4626-0063 |
| Cyclosporine/tacrolimus | dog | FDA-2018-N-4626-0108 |
| Cyproheptadine HCl | dog, cat, horse | FDA-2018-N-4626-0102 |
| Dantrolene sodium | dog, cat, horse | FDA-2018-N-4626-0095 |
| Decoquinate | dog, horse | FDA-2018-N-4626-0126 |
| Demecarium bromide | dog | FDA-2018-N-4626-0028 |
| Desmopressin | dog, cat, horse | FDA-2018-N-4626-0031 |
| Dexamethasone | dog, cat, horse horse |
FDA-2018-N-4626-0082 FDA-2018-N-4626-0098 |
| Diazoxide | dog | FDA-2018-N-4626-0096 |
| Diclazuril | dog, cat, horse | FDA-2018-N-4626-0109 |
| Diclofenac sodium | dog, cat, horse | FDA-2018-N-4626-0538 |
| Diethylstilbestrol (DES) | dog | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Diltiazem | dog, cat | FDA-2018-N-4626-0731 |
| Dimercaptosuccinic acid (DMSA) | dog, cat | FDA-2018-N-4626-0714 |
| Dimethyl sulfoxide (DMSO) | dog, horse | FDA-2018-N-4626-0618 |
| Doxycycline | dog, cat, horse | FDA-2018-N-4626-0011 FDA-2018-N-4626-0015 FDA-2018-N-4626-0812 |
| Doxycycline/clindamycin | dog | FDA-2018-N-4626-0116 |
| Edetate calcium disodium | dog, cat, horse | FDA-2018-N-4626-0482 |
| Enalapril maleate | dog, cat | FDA-2018-N-4626-0049 |
| Enalapril maleate/furosemide/pimobendan | dog, cat | FDA-2018-N-4626-0179 |
| Enrofloxacin/itraconazole/triamcinolone | dog, cat | FDA-2018-N-4626-0627 |
| Enrofloxacin/miconazole/triamcinolone | dog, cat | FDA-2018-N-4626-0625 |
| Ertugliflozin | horse | FDA-2018-N-4626-0737 |
| Erythromycin ethylsuccinate | dog, cat, horse | FDA-2018-N-4626-0479 |
| Estrone | horse | FDA-2018-N-4626-0117 |
| Fenbendazole/ponazuril/praziquantel | dog, cat | FDA-2018-N-4626-0178 |
| Fipronil | dog, cat | FDA-2018-N-4626-0637 |
| Fluconazole | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0059 |
| Fludrocortisone acetate | dog, cat | FDA-2018-N-4626-0159 |
| Flurbiprofen | horse | FDA-2018-N-4626-0654 |
| Fluorouracil | dog, horse | FDA-2018-N-4626-0171 |
| Flurbiprofen | horse | FDA-2018-N-4626-0654 |
| Fomepizole | dog, cat | FDA-2018-N-4626-0656 FDA-2018-N-4626-0725 |
| Furosemide | dog, cat, horse | FDA-2018-N-4626-0076 |
| Gabapentin | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0051 FDA-2018-N-4626-0084 |
| Gabapentin/trazodone HCl | dog, cat | FDA-2018-N-4626-0128 FDA-2018-N-4626-0638 |
| Glycopyrrolate | dog, cat, horse | FDA-2018-N-4626-0584 |
| Gramicidin/neomycin/nystatin/triamcinolone | dog, cat, horse | FDA-2018-N-4626-0176 |
| Griseofulvin | dog, horse | FDA-2018-N-4626-0148 |
| Guaifenesin | horse | FDA-2018-N-4626-0028 |
| Guanabenz acetate | horse | FDA-2018-N-4626-0742 |
| Hydrocodone bitartrate | dog | FDA-2018-N-4626-0062 FDA-2018-N-4626-0592 |
| Hydrocodone homatropine | dog | FDA-2018-N-4626-0593 |
| Idoxuridine | cat, horse | FDA-2018-N-4626-0024 |
| Imipenem/cilastatin/ketoconazole/triamcinolone | dog, cat | FDA-2018-N-4626-0555 |
| Isoxsuprine HCl | horse | FDA-2018-N-4626-0092 |
| Itraconazole with DMSO | horse | FDA-2018-N-4626-0028 |
| Kanamycin/bismuth subcarbonate/kaolin | dog, cat | FDA-2018-N-4626-0630 |
| Ketoconazole | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0035 |
| Ketoconazole/amikacin/triamcinolone | dog, cat | FDA-2018-N-4626-0156 FDA-2018-N-4626-0551 |
| Ketoconazole/enrofloxacin/betamethasone | dog, cat | FDA-2018-N-4626-0628 |
| Ketoconazole/enrofloxacin/mupirocin/triamcinolone | dog, cat | FDA-2018-N-4626-0626 |
| Ketoconazole/enrofloxacin/triamcinolone | dog, cat | FDA-2018-N-4626-0084 FDA-2018-N-4626-0099 FDA-2018-N-4626-0553 |
| Ketoconazole/marbofloxacin/polymyxin B/triamcinolone | dog, cat | FDA-2018-N-4626-0624 |
| Ketoconazole/marbofloxacin/triamcinolone | dog, cat | FDA-2018-N-4626-0623 |
| Ketoconazole/mupirocin/silver sulfadiazine/triamcinolone | dog, cat, horse | FDA-2018-N-4626-0622 |
| Ketoconazole/mupirocin/triamcinolone | dog, cat, horse | FDA-2018-N-4626-0590 |
| Ketoconazole/ polymyxin B/triamcinolone | dog, cat | FDA-2018-N-4626-0621 |
| Ketoconazole/triamcinolone | dog, cat | FDA-2018-N-4626-0589 |
| L-asparaginase | dog, cat | FDA-2018-N-4626-0028 FDA-2018-N-4626-0032 FDA-2018-N-4626-0725 |
| Lapatinib | dog, cat | FDA-2018-N-4626-0726 |
| Levetiracetam | dog, cat, horse | FDA-2018-N-4626-0064 |
| Lomustine | dog, cat | FDA-2018-N-4626-0067 |
| Magnesium sulfate/tryptophan (L) | horse | FDA-2018-N-4626-0150 |
| Mechlorethamine HCl | dog, cat | FDA-2018-N-4626-0105 FDA-2018-N-4626-0725 |
| Meclofenamate sodium | horse | FDA-2018-N-4626-0715 |
| Meloxicam | dog, cat dog, cat, horse |
FDA-2018-N-4626-0013 FDA-2018-N-4626-0029 FDA-2018-N-4626-0046 FDA-2018-N-4626-0585 |
| Melphalan | dog, cat | FDA-2018-N-4626-0719 FDA-2018-N-4626-0753 |
| Methazolamide | dog, cat | FDA-2018-N-4626-0160 |
| Methylprednisolone | dog, cat, horse | FDA-2018-N-4626-0586 |
| Metoclopramide HCl | dog, cat, horse | FDA-2018-N-4626-0077 |
| Metronidazole benzoate |
dog, cat, horse cat |
|
| Mibolerone | dog | FDA-2018-N-4626-0725 |
| Minocycline HCl | dog, cat, horse | FDA-2018-N-4626-0124 |
| Misoprostol | dog, cat, horse | FDA-2018-N-4626-0127 |
| Mitomycin | dog, horse | FDA-2018-N-4626-0738 |
| Mupirocin | dog, cat | FDA-2018-N-4626-0033 |
| Mycophenolate mofetil | dog, cat | FDA-2018-N-4626-0153 |
| Nalbuphine | dog, cat, horse | FDA-2018-N-4626-0712 |
| Nalbuphine HCl/azaperone/medetomidine HCl | horse | FDA-2018-N-4626-0653 |
| Naltrexone HCl | horse | FDA-2018-N-4626-0733 |
| Nitrofurantoin | dog, cat | FDA-2018-N-4626-0172 |
| Oseltamivir | dog | FDA-2018-N-4626-0033 |
| Paromomycin sulfate | dog, cat | FDA-2018-N-4626-0184 |
| Penicillamine | dog, cat | FDA-2018-N-4626-0141 |
| Pentoxifylline | dog, cat, horse | FDA-2018-N-4626-0119 |
| Phenobarbital | dog. cat | FDA-2018-N-4626-0080 FDA-2018-N-4626-0591 |
| Phenoxybenzamine HCl | dog, cat | FDA-2018-N-4626-0068 FDA-2018-N-4626-0658 |
| Piroxicam | dog, cat, horse | FDA-2018-N-4626-0060 |
| Ponazuril | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 FDA-2018-N-4626-0073 |
| Potassium bromide | dog, horse | FDA-2018-N-4626-0022 |
| Prednisolone | dog, cat, horse | FDA-2018-N-4626-0033 FDA-2018-N-4626-0036 FDA-2018-N-4626-0074 |
| Prednisone | dog | FDA-2018-N-4626-0075 |
| Procarbazine HCl | dog, cat | FDA-2018-N-4626-0669 FDA-2018-N-4626-0725 |
| Progesterone | horse | FDA-2018-N-4626-0815 |
| Pyrimethamine | dog, cat, horse | FDA-2018-N-4626-0078 |
| Pyrimethamine/sulfadiazine | horse | FDA-2018-N-4626-0151 |
| Pyrimethamine/sulfadiazine/folic acid | horse | FDA-2018-N-4626-0180 |
| Riboflavin | dog, cat, horse | FDA-2018-N-4626-0722 |
| Rifampin | dog, cat | FDA-2018-N-4626-0061 |
| Romifidine HCl | horse | FDA-2018-N-4626-0113 |
| Ronidazole | dog, cat | FDA-2018-N-4626-0142 FDA-2018-N-4626-0582 |
| Secnidazole | dog, cat | FDA-2018-N-4626-0033 FDA-2018-N-4626-0173 |
| Sildenafil citrate | dog, cat | FDA-2018-N-4626-0072 |
| Sirolimus | dog, cat | FDA-2018-N-4626-0674 |
| Sodium carboxymethylcellulose | horse | FDA-2018-N-4626-0741 |
| Sotalol HCl | dog, cat | FDA-2018-N-4626-0813 |
| Spironolactone | dog, cat | FDA-2018-N-4626-0143 |
| Stanozolol | dog, cat dog, cat, horse |
FDA-2018-N-4626-0757 FDA-2018-N-4626-0581 |
| Tacrolimus | dog | FDA-2018-N-4626-0023 |
| Terbinafine HCl | dog, cat | FDA-2018-N-4626-0165 |
| Terbutaline sulfate | dog, cat | FDA-2018-N-4626-0168 |
| Theophylline | dog, cat | FDA-2018-N-4626-0033 FDA-2018-N-4626-0037 |
| Ticarcillin disodium/clavulanate potassium | horse | FDA-2018-N-4626-0756 |
| Tissue plasminogen activator (TPA) | dog, cat | FDA-2018-N-4626-0701 |
| Tolazoline HCl | horse | FDA-2018-N-4626-0028 |
| Toltrazuril | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Toltrazuril/DMSO | horse | FDA-2018-N-4626-0157 |
| Tramadol | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0033 FDA-2018-N-4626-0065 |
| Trazodone HCl | dog, cat, horse | FDA-2018-N-4626-0110 |
| Triamcinolone acetonide | dog, cat, horse | FDA-2018-N-4626-0033 FDA-2018-N-4626-0094 FDA-2018-N-4626-0657 |
| Trichlormethiazide/dexamethasone | horse | FDA-2018-N-4626-0149 |
| Tryptophan (L)/thiamine HCl | horse | FDA-2018-N-4626-0163 |
| Tryptophan/thiamine HCl/folic acid/niacin | horse | FDA-2018-N-4626-0161 |
| Tylosin | dog, cat | FDA-2018-N-4626-0071 |
| Ursodiol | dog, cat, horse | FDA-2018-N-4626-0033 FDA-2018-N-4626-0044 |
| Vitamin A, D, E | dog, cat | FDA-2018-N-4626-0723 |
| Voriconazole | dog, cat, horse dog, cat |
FDA-2018-N-4626-0122 FDA-2018-N-4626-0701 |
| Yohimbine HCl | dog, cat, horse | FDA-2018-N-4626-0013 |
| Zonisamide | dog, cat | FDA-2018-N-4626-0057 |
NONFOOD-PRODUCING MINOR SPECIES
| Bulk Drug Substance (BDS) | Species | Nomination |
|---|---|---|
| Aluminum hydroxide | rodents, small mammals | FDA-2018-N-4626-0048 |
| Amitriptyline HCl | bird | FDA-2018-N-4626-0018 |
| Apomorphine HCl | ferret | FDA-2018-N-4626-0020 |
| Atipamezole | African hoof stock, camelids, carnivores, captive zoo species | FDA-2018-N-4626-0054 FDA-2018-N-4626-0801 |
| Azaperone | African hoof stock, camelids, minor carnivore spp., and small mammals | FDA-2018-N-4626-0013 |
| Azithromycin/rifampin | bird | FDA-2018-N-4626-0090 |
| Butorphanol/azaperone/medetomidine (BAM) | African hoof stock, camelids, carnivores, feral horses, and small mammals | FDA-2018-N-4626-0085 |
| Butorphanol tartrate | African hoof stock, elephants, rhinos, camelids, minor carnivore species, zoo/captive goat species | FDA-2018-N-4626-0013 |
| Carprofen | non-human primates | FDA-2018-N-4626-0477 |
| Cephalexin | non-human primates | FDA-2018-N-4626-0478 |
| Chlorambucil | ferret | FDA-2018-N-4626-0123 |
| Cisapride | rodents, other small mammals, and captive marine mammals | FDA-2018-N-4626-0021 FDA-2018-N-4626-0655 FDA-2018-N-4626-0759 |
| Clindamycin HCl | avian, ferret, reptiles, assorted exotic and zoo species avian |
FDA-2018-N-4626-0042 FDA-2018-N-4626-0583 |
| Cyclophosphamide | ferret | FDA-2018-N-4626-0063 |
| Dexamethasone | ferret, rodents camelids |
FDA-2018-N-4626-0082 FDA-2018-N-4626-0098 |
| Diazoxide | ferret, guinea pig, small mammals | FDA-2018-N-4626-0096 |
| Dimercaptosuccinic acid (DMSA) | avian | FDA-2018-N-4626-0714 |
| Doxycycline | rodents, small mammals, birds, reptiles, other exotic and zoo animals whales, dolphins, porpoises |
FDA-2018-N-4626-0015 FDA-2018-N-4626-0673 |
| Edetate calcium disodium (calcium disodium edetate) | birds captive eagles, California condors, other raptors |
FDA-2018-N-4626-0482 FDA-2018-N-4626-0523 FDA-2018-N-4626-0558 |
| Enalapril maleate | ferret, bird | FDA-2018-N-4626-0049 FDA-2018-N-4626-0084 |
| Fenbendazole | small mammals, assorted exotic and captive zoo species | FDA-2018-N-4626-0174 |
| Fluconazole | bird, exotics, small mammal, exotics, captive zoo species, reptile | FDA-2018-N-4626-0032 FDA-2018-N-4626-0059 |
| Furosemide | ferret, small mammals, bird, reptile | FDA-2018-N-4626-0076 |
| Gabapentin | avian, exotics, zoo animals | FDA-2018-N-4626-0051 |
| Griseofulvin | rodents, small mammals, captive exotic and zoo species | FDA-2018-N-4626-0148 |
| Isoxsuprine HCl | bird | FDA-2018-N-4626-0092 |
| Ketoconazole | bird, exotics, zoo species, rodents, reptiles, small animals | FDA-2018-N-4626-0032 FDA-2018-N-4626-0035 |
| Ketoconazole/mupirocin/triamcinolone | avian, ferrets, small mammals | FDA-2018-N-4626-0590 |
| L-asparaginase | ferrets | FDA-2018-N-4626-0725 |
| Marbofloxacin | avian, reptiles, assorted captive exotic and zoo species | FDA-2018-N-4626-0070 |
| Medetomidine/ketamine | African hoof stock, camelids, carnivores, feral horses, and small mammals | FDA-2018-N-4626-0189 |
| Meloxicam | birds, rats, mice, gerbils, hamsters, other small mammals, marine mammals, large zoo animals and captive wildlife, ferrets, reptiles, assorted exotic and zoo animals avian, ferrets, rats, guinea pigs |
FDA-2018-N-4626-0029 FDA-2018-N-4626-0046 FDA-2018-N-4626-0585 |
| Metoclopramide HCl | small mammals | FDA-2018-N-4626-0077 |
| Metronidazole benzoate |
small mammals, exotic species pet/captive birds |
|
| Nalbuphine HCl/ azaperone/medetomidine HCl | African hoof stock, camelids, minor carnivore species, zoo/captive goat species, small mammals | FDA-2018-N-4626-0653 |
| Naltrexone | African hoof stock, camelids, minor carnivore species, zoo/captive goat species, small mammals | FDA-2018-N-4626-0733 |
| Oxantel pamoate/praziquantel/pyrantel pamoate | ferret, reptile | FDA-2018-N-4626-0130 |
| Paromomycin sulfate | elephant, reptile | FDA-2018-N-4626-0184 |
| Penicillamine | avian | FDA-2018-N-4626-0141 |
| Piroxicam | small mammals | FDA-2018-N-4626-0060 |
| Ponazuril | small mammals, reptiles, assorted exotic species | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Prednisolone | avian, rodents, small mammals, reptiles, other exotic and zoo species | FDA-2018-N-4626-0074 |
| Prednisone | avian, rodents, small mammals | FDA-2018-N-4626-0075 |
| Pyrimethamine | avian, exotics | FDA-2018-N-4626-0078 |
| Sildenafil citrate | assorted exotic and captive zoo species | FDA-2018-N-4626-0072 |
| Stanozolol | small mammals avian |
FDA-2018-N-4626-0081 FDA-2018-N-4626-0581 |
| Terbinafine HCl | avian bottlenose dolphins, California sea lions |
FDA-2018-N-4626-0165 FDA-2018-N-4626-0662 |
| Toltrazuril | small mammals, reptiles, camelids, assorted large and small exotic/zoo species | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Tramadol HCl | avian, sea turtle, ungulates, small mammals, reptiles, captive zoo and exotic species | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 FDA-2018-N-4626-0033 FDA-2018-N-4626-0065 |
| Tylosin | ferrets, exotic and captive zoo species | FDA-2018-N-4626-0071 |
| Ursodiol | bird | FDA-2018-N-4626-0044 |
| Vitamin A, D, E | bird, gecko | FDA-2018-N-4626-0723 |
| Voriconazole | bird | FDA-2018-N-4626-0122 |
| Yohimbine HCl | small mammals, zoo/captive bird species, pet birds, llama, large and small exotic/zoo species | FDA-2018-N-4626-0013 |
FOOD-PRODUCING ANIMALS (ANTIDOTES)
| Bulk Drug Substance (BDS) | Species | Nomination |
|---|---|---|
| Methylene blue | cattle, sheep, goats | FDA-2018-N-4626-0730 |
FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS)
| Bulk Drug Substance (BDS) | Species | Nomination |
|---|---|---|
| Atipamezole | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and other free-ranging wildlife | FDA-2018-N-4626-0054 FDA-2018-N-4626-0801 |
| Azaperone | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, free-ranging goat species | FDA-2018-N-4626-0013 |
| Butorphanol/azaperone/medetomidine (BAM) | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and small mammals | FDA-2018-N-4626-0085 |
| Butorphanol tartrate | North American hoof stock; large ungulates including deer, elk, moose, bighorn sheep | FDA-2018-N-4626-0013 |
| Medetomidine HCl/ketamine HCl | North American hoof stock; large ungulates including deer, elk, moose, bighorn sheep | FDA-2018-N-4626-0189 |
| Nalbuphine HCl/ azaperone/medetomidine HCl | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep | FDA-2018-N-4626-0653 |
| Naltrexone HCl | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep | FDA-2018-N-4626-0733 |