Details for New Drug Application (NDA): 090624
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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 090624
Tradename: | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
Applicant: | Aurobindo Pharma |
Ingredient: | sulfamethoxazole; trimethoprim |
Patents: | 0 |
Suppliers and Packaging for NDA: 090624
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 090624 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8121 | 0615-8121-10 | 10 TABLET in 1 BLISTER PACK (0615-8121-10) |
SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 090624 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8121 | 0615-8121-14 | 14 TABLET in 1 BLISTER PACK (0615-8121-14) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG;80MG | ||||
Approval Date: | Feb 16, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG;160MG | ||||
Approval Date: | Feb 16, 2010 | TE: | AB | RLD: | No |
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