Details for New Drug Application (NDA): 206129
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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 206129
Tradename: | TETRABENAZINE |
Applicant: | Sun Pharm |
Ingredient: | tetrabenazine |
Patents: | 0 |
Pharmacology for NDA: 206129
Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 206129
Suppliers and Packaging for NDA: 206129
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 206129 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-179 | 47335-179-23 | 112 TABLET in 1 BOTTLE (47335-179-23) |
TETRABENAZINE | tetrabenazine | TABLET;ORAL | 206129 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-277 | 47335-277-23 | 112 TABLET in 1 BOTTLE (47335-277-23) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Aug 17, 2015 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Aug 17, 2015 | TE: | RLD: | No |
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