Details for New Drug Application (NDA): 076899
✉ Email this page to a colleague
The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM is phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim profile page.
Summary for 076899
Tradename: | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
Applicant: | Amneal Pharms Ny |
Ingredient: | sulfamethoxazole; trimethoprim |
Patents: | 0 |
Suppliers and Packaging for NDA: 076899
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 076899 | ANDA | Major Pharmaceuticals | 0904-2725 | 0904-2725-61 | 100 BLISTER PACK in 1 CARTON (0904-2725-61) / 1 TABLET in 1 BLISTER PACK |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 076899 | ANDA | AvKARE | 42291-758 | 42291-758-01 | 100 TABLET in 1 BOTTLE (42291-758-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG;80MG | ||||
Approval Date: | Jan 27, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG;160MG | ||||
Approval Date: | Jan 27, 2005 | TE: | AB | RLD: | No |
Complete Access Available with Subscription