Details for New Drug Application (NDA): 074884
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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 074884
Tradename: | CLEMASTINE FUMARATE |
Applicant: | New Heightsrx |
Ingredient: | clemastine fumarate |
Patents: | 0 |
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: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 0.5MG BASE/5ML | ||||
Approval Date: | Dec 17, 1997 | TE: | AA | RLD: | No |
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