Details for New Drug Application (NDA): 074884
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NDA 074884 describes CLEMASTINE FUMARATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Genus, New Heights, Teva Pharms, Wockhardt Bio Ag, Ani Pharms, L Perrigo Co, Pld Acquisitions Llc, Sandoz, and Teva, and is included in eleven NDAs. It is available from three 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
Summary for 074884
| Tradename: | CLEMASTINE FUMARATE |
| Applicant: | New Heights |
| Ingredient: | clemastine fumarate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 074884
Suppliers and Packaging for NDA: 074884
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 074884 | ANDA | Chartwell RX, LLC | 62135-713 | 62135-713-41 | 120 mL in 1 BOTTLE (62135-713-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | EQ 0.5MG BASE/5ML | ||||
| Approval Date: | Dec 17, 1997 | TE: | RLD: | No | |||||
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