Details for New Drug Application (NDA): 073399
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NDA 073399 describes CLEMASTINE FUMARATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Genus, New Heightsrx, Teva Pharms, Wockhardt Bio Ag, Ani Pharms, L Perrigo Co, Omnivium Pharms, Pld Acquisitions Llc, and Teva, and is included in eleven NDAs. It is available from four suppliers. Additional details are available on the CLEMASTINE FUMARATE profile page.
The generic ingredient in CLEMASTINE FUMARATE is clemastine fumarate. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
The generic ingredient in CLEMASTINE FUMARATE is clemastine fumarate. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
Summary for 073399
| Tradename: | CLEMASTINE FUMARATE |
| Applicant: | Genus |
| Ingredient: | clemastine fumarate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 073399
Suppliers and Packaging for NDA: 073399
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 073399 | ANDA | Genus Lifesciences | 64950-324 | 64950-324-12 | 120 mL in 1 BOTTLE (64950-324-12) |
| CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 073399 | ANDA | Ayurax, LLC | 73308-358 | 73308-358-12 | 120 mL in 1 BOTTLE, PLASTIC (73308-358-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 0.5MG BASE/5ML | ||||
| Approval Date: | Jun 30, 1994 | TE: | AA | RLD: | No | ||||
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