Details for New Drug Application (NDA): 077714
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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 077714
Tradename: | TERBINAFINE HYDROCHLORIDE |
Applicant: | Breckenridge Pharm |
Ingredient: | terbinafine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 077714
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077714 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-906 | 43063-906-20 | 20 TABLET in 1 BOTTLE, PLASTIC (43063-906-20) |
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077714 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-906 | 43063-906-42 | 42 TABLET in 1 BOTTLE, PLASTIC (43063-906-42) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jun 4, 2010 | TE: | AB | RLD: | No |
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