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 | A-S Medication Solutions | 50090-0525 | 50090-0525-0 | 473 mL in 1 BOTTLE (50090-0525-0) |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 091348 | ANDA | Aurobindo Pharma Limited | 65862-496 | 65862-496-01 | 100 mL in 1 BOTTLE (65862-496-01) |
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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