Details for New Drug Application (NDA): 077511
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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 077511
Tradename: | TERBINAFINE HYDROCHLORIDE |
Applicant: | Taro |
Ingredient: | terbinafine hydrochloride |
Patents: | 0 |
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 | Walgreen Company | 0363-2080 | 0363-2080-01 | 1 TUBE in 1 CARTON (0363-2080-01) / 15 g in 1 TUBE |
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511 | ANDA | Walgreen Company | 0363-2080 | 0363-2080-02 | 1 TUBE in 1 CARTON (0363-2080-02) / 30 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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