Details for New Drug Application (NDA): 091348
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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 091348
Tradename: | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
Applicant: | Aurobindo Pharma |
Ingredient: | sulfamethoxazole; trimethoprim |
Patents: | 0 |
Suppliers and Packaging for NDA: 091348
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 091348 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0496 | 17856-0496-4 | 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1) |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 091348 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0496 | 17856-0496-5 | 50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 200MG/5ML;40MG/5ML | ||||
Approval Date: | Jun 8, 2010 | TE: | AB | RLD: | No |
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