Details for New Drug Application (NDA): 077137
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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 077137
Tradename: | TERBINAFINE HYDROCHLORIDE |
Applicant: | Cipla |
Ingredient: | terbinafine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 077137
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077137 | ANDA | Proficient Rx LP | 63187-792 | 63187-792-30 | 30 TABLET in 1 BOTTLE (63187-792-30) |
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077137 | ANDA | Proficient Rx LP | 63187-792 | 63187-792-35 | 35 TABLET in 1 BOTTLE (63187-792-35) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jul 2, 2007 | TE: | RLD: | No |
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