Details for New Drug Application (NDA): 073399
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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 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 | 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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