NADA Number: 141-080 | |
| Proprietary Name |
Anipryl® |
|---|---|
| Sponsor |
Pfizer, Inc. |
| Sponsor Address |
235 East 42d St. New York, NY 10017 USA |
| Ingredients |
Selegiline Hydrochloride |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Tablet |
| Drug Form |
Tablet |
| Dispensing Status |
OTC |
| Patent Number |
5151449 5192808 5225446 5276057 5387615 5561163 5565495 |
| Exclusivity |
Granted for addition of a new claim for the control of clinical signs associated with canine Cognitive Dysfunction Syndrome at a new dose of 0.5-1.0 mg/kg. No active ingredient of the drug has been previously approved. |
|
Dosage Amount, Indications & Limitations |
520.2098 Selegiline hydrochloride tablets. Specifications: Each tablet contains either 2, 5, 10, 15, or 30 milligrams of selegiline hydrochloride. Conditions of use: Dogs Amount 1 milligram per kilogram (0.45 milligram per pound) of body weight. Indications: For control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism in dogs. Limitations: Administer orally once daily. If no improvement in clinical signs or physical examination findings after 2 months of therapy, increase dose to a maximum of 2 milligrams per kilogram once daily. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Amount: 0.5 to 1.0 milligram per kilogram of body weight once daily. Indications: For the control of clinical signs associated with canine cognitive dysfunction syndrome Limitations: Administer orally once daily. If no improvement in clinical signs or physical examination findings after 2 months of therapy, increase dose to a maximum of 2 milligrams per kilogram once daily. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |