Phenylbutazone Tablets, USP 100 mg - Share Your Phenylbutazone Tablets, USP 100 mg Experience with Community:
blog comments powered by DisqusNADA Number: 094-170 | |
| Proprietary Name |
Phenylbutazone Tablets, USP 100 mg Phenylbute™ Tablets 100 mg Phenylbutazone Tablets, USP 200 mg |
|---|---|
| Sponsor |
Teva Animal Health, Inc. |
| Sponsor Address |
3915 South 48th Street Ter. St. Joseph, MO 64506 USA |
| Ingredients |
Phenylbutazone |
| Species |
Horse, not for meat production Dog, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Tablet |
| Drug Form |
Tablet |
| Dispensing Status |
RX |
| Exclusivity |
Granted for the addition of a 200 milligram strength tablet for use in dogs. |
|
Dosage Amount, Indications & Limitations |
520.1720a Phenylbutazone tablets and boluses. Specifications: Each tablet contains 100 or 200 milligrams, or 1 gram. Conditions of use: Dogs Amount: Twenty milligrams per pound of body weight daily. Indications: The drug is used for the relief of inflammatory conditions associated with a musculoskeletal system. Limitations: Administer in three divided doses daily. Do not exceed a total daily dose of 800 milligrams regardless of body weight. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at a level capable of producing the desired clinical response. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Horses Amount: One to two grams per 500 pounds weight daily. Indications: The drug is used for the relief of inflammatory conditions associated with a musculoskeletal system. Limitations: Do not exceed a daily dose of 4 grams per day. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at a level capable of producing the desired clinical response. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. NAS/NRC status: These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by 514.111 of this chapter, but may require bioequivalency and safety information. |