Details for New Drug Application (NDA): 074028
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The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 074028
Tradename: | AMANTADINE HYDROCHLORIDE |
Applicant: | Chartwell Rx |
Ingredient: | amantadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074028
Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for 074028
Suppliers and Packaging for NDA: 074028
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 074028 | ANDA | Chartwell RX, LLC | 62135-010 | 62135-010-47 | 473 mL in 1 BOTTLE (62135-010-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 50MG/5ML | ||||
Approval Date: | Jun 28, 1993 | TE: | AA | RLD: | No |
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