Details for New Drug Application (NDA): 077533
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NDA 077533 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-two 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-six 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-six suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.
Summary for 077533
| Tradename: | TERBINAFINE HYDROCHLORIDE |
| Applicant: | Invagen Pharms |
| Ingredient: | terbinafine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077533 | ANDA | Cipla USA Inc. | 69097-859 | 69097-859-02 | 30 TABLET in 1 BOTTLE (69097-859-02) |
| TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077533 | ANDA | Cipla USA Inc. | 69097-859 | 69097-859-07 | 100 TABLET in 1 BOTTLE (69097-859-07) |
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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