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Details for New Drug Application (NDA): 077511
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NDA 077511 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Apotex, Aurobindo Pharma, Breckenridge Pharm, Cipla, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Heritage Pharma, Invagen Pharms, Mylan, Orchid Hlthcare, Roxane, and Wockhardt, and is included in sixteen NDAs. It is available from forty-eight 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.
Summary for 077511
| Tradename: | TERBINAFINE HYDROCHLORIDE |
| Applicant: | Taro |
| Ingredient: | terbinafine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077511
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511 | ANDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0067-8100 | 0067-8100-12 | 1 TUBE in 1 CARTON (0067-8100-12) > 12 g in 1 TUBE |
| TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511 | ANDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0067-8100 | 0067-8100-15 | 1 TUBE in 1 CARTON (0067-8100-15) > 15 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Jul 2, 2007 | TE: | RLD: | No | |||||
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