Details for New Drug Application (NDA): 078297
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NDA 078297 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Dr Reddys Labs Inc, Emed Medcl, Gedeon Richter Usa, Glenmark Pharms Ltd, Heritage Pharma Avet, Invagen Pharms, Mylan, Natco Pharma, Orbion Pharms, Roxane, and Wockhardt, and is included in sixteen NDAs. It is available from forty-one suppliers. Additional details are available on the TERBINAFINE HYDROCHLORIDE profile page.
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.
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 078297
| Tradename: | TERBINAFINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | terbinafine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078297
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 078297 | ANDA | NorthStar Rx LLC | 16714-795 | 16714-795-01 | 30 TABLET in 1 BOTTLE (16714-795-01) |
| TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 078297 | ANDA | NorthStar Rx LLC | 16714-795 | 16714-795-02 | 100 TABLET in 1 BOTTLE (16714-795-02) |
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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