Details for New Drug Application (NDA): 071017
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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 071017
Tradename: | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
Applicant: | Sun Pharm Industries |
Ingredient: | sulfamethoxazole; trimethoprim |
Patents: | 0 |
Suppliers and Packaging for NDA: 071017
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 071017 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-145 | 53489-145-01 | 100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01) |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 071017 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-145 | 53489-145-05 | 500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG;160MG | ||||
Approval Date: | Aug 25, 1986 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG;80MG | ||||
Approval Date: | Aug 25, 1986 | TE: | AB | RLD: | No |
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