Details for New Drug Application (NDA): 213316
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NDA 213316 describes TETRABENAZINE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Apotex, Bionpharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Hikma, Mylan, Slate Run Pharma, and Sun Pharm, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the TETRABENAZINE profile page.
The generic ingredient in TETRABENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
The generic ingredient in TETRABENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
Summary for 213316
| Tradename: | TETRABENAZINE |
| Applicant: | Slate Run Pharma |
| Ingredient: | tetrabenazine |
| Patents: | 0 |
Pharmacology for NDA: 213316
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 213316
Suppliers and Packaging for NDA: 213316
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TETRABENAZINE | tetrabenazine | TABLET;ORAL | 213316 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-101 | 70436-101-09 | 112 TABLET in 1 BOTTLE (70436-101-09) |
| TETRABENAZINE | tetrabenazine | TABLET;ORAL | 213316 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-102 | 70436-102-09 | 112 TABLET in 1 BOTTLE (70436-102-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Jan 22, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jan 22, 2020 | TE: | AB | RLD: | No | ||||
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