Details for New Drug Application (NDA): 073283
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The generic ingredient in CLEMASTINE FUMARATE is clemastine fumarate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
Summary for 073283
Tradename: | CLEMASTINE FUMARATE |
Applicant: | Teva |
Ingredient: | clemastine fumarate |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 073283
Suppliers and Packaging for NDA: 073283
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLEMASTINE FUMARATE | clemastine fumarate | TABLET;ORAL | 073283 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0308 | 0093-0308-01 | 100 TABLET in 1 BOTTLE (0093-0308-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.68MG | ||||
Approval Date: | Jan 31, 1992 | TE: | RLD: | No |
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