Details for New Drug Application (NDA): 213621
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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 213621
Tradename: | TETRABENAZINE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | tetrabenazine |
Patents: | 0 |
Pharmacology for NDA: 213621
Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 213621
Suppliers and Packaging for NDA: 213621
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 213621 | ANDA | Ajanta Pharma USA Inc. | 27241-176 | 27241-176-13 | 112 TABLET in 1 BOTTLE (27241-176-13) |
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 213621 | ANDA | Ajanta Pharma USA Inc. | 27241-177 | 27241-177-13 | 112 TABLET in 1 BOTTLE (27241-177-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Dec 4, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 4, 2020 | TE: | RLD: | No |
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