Details for New Drug Application (NDA): 212231
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NDA 212231 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM, which is a drug marketed by Abraxis Pharm, Bedford, Hikma, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Watson Labs, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Sun Pharm Industries, Usl Pharma, Vista Pharms, Able, and Heritage Pharma Avet, and is included in forty-seven NDAs. It is available from forty-six suppliers. Additional details are available on the SULFAMETHOXAZOLE AND TRIMETHOPRIM profile page.
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.
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 212231
| Tradename: | SULFAMETHOXAZOLE AND TRIMETHOPRIM |
| Applicant: | Somerset |
| Ingredient: | sulfamethoxazole; trimethoprim |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212231
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | INJECTABLE;INJECTION | 212231 | ANDA | Somerset Therapeutics, LLC | 70069-361 | 70069-361-10 | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | sulfamethoxazole; trimethoprim | INJECTABLE;INJECTION | 212231 | ANDA | Somerset Therapeutics, LLC | 70069-362 | 70069-362-10 | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML;16MG/ML | ||||
| Approval Date: | Jun 26, 2019 | TE: | AP | RLD: | No | ||||
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