Details for New Drug Application (NDA): 076390
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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 076390
Tradename: | TERBINAFINE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Inc |
Ingredient: | terbinafine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 076390
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 076390 | ANDA | Dr.Reddys Laboratories Limited | 55111-250 | 55111-250-01 | 100 TABLET in 1 BOTTLE (55111-250-01) |
TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 076390 | ANDA | Dr.Reddys Laboratories Limited | 55111-250 | 55111-250-05 | 500 TABLET in 1 BOTTLE (55111-250-05) |
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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