Details for New Drug Application (NDA): 078199
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The generic ingredient in TERBINAFINE HYDROCHLORIDE is terbinafine hydrochloride. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.
Summary for 078199
Tradename: | TERBINAFINE HYDROCHLORIDE |
Applicant: | Chartwell |
Ingredient: | terbinafine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 078199
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 078199 | ANDA | Chartwell RX, LLC | 62135-572 | 62135-572-30 | 30 TABLET in 1 BOTTLE (62135-572-30) |
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 078199 | ANDA | Chartwell RX, LLC | 62135-572 | 62135-572-90 | 90 TABLET in 1 BOTTLE (62135-572-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jul 2, 2007 | TE: | AB | RLD: | No |
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