Details for New Drug Application (NDA): 207682
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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 207682
Tradename: | TETRABENAZINE |
Applicant: | Mylan |
Ingredient: | tetrabenazine |
Patents: | 0 |
Pharmacology for NDA: 207682
Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 207682
Suppliers and Packaging for NDA: 207682
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 207682 | ANDA | TAGI Pharma, Inc. | 51224-425 | 51224-425-10 | 112 TABLET in 1 BOTTLE (51224-425-10) |
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 207682 | ANDA | TAGI Pharma, Inc. | 51224-426 | 51224-426-10 | 112 TABLET in 1 BOTTLE (51224-426-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Jan 31, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jan 31, 2017 | TE: | AB | RLD: | No |
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