Details for New Drug Application (NDA): 206093
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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 206093
Tradename: | TETRABENAZINE |
Applicant: | Apotex |
Ingredient: | tetrabenazine |
Patents: | 0 |
Pharmacology for NDA: 206093
Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 206093
Suppliers and Packaging for NDA: 206093
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 206093 | ANDA | Golden State Medical Supply, Inc. | 51407-480 | 51407-480-12 | 112 TABLET in 1 BOTTLE (51407-480-12) |
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 206093 | ANDA | Golden State Medical Supply, Inc. | 51407-481 | 51407-481-12 | 112 TABLET in 1 BOTTLE (51407-481-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Mar 17, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Mar 17, 2020 | TE: | AB | RLD: | No |
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