Details for New Drug Application (NDA): 208826
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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 208826
Tradename: | TETRABENAZINE |
Applicant: | Bionpharma |
Ingredient: | tetrabenazine |
Patents: | 0 |
Pharmacology for NDA: 208826
Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 208826
Suppliers and Packaging for NDA: 208826
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 208826 | ANDA | Bionpharma Inc. | 69452-117 | 69452-117-21 | 112 TABLET in 1 BOTTLE (69452-117-21) |
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 208826 | ANDA | Bionpharma Inc. | 69452-118 | 69452-118-21 | 112 TABLET in 1 BOTTLE (69452-118-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Dec 18, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 18, 2017 | TE: | AB | RLD: | No |
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