Details for New Drug Application (NDA): 211572
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NDA 211572 describes TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, which is a drug marketed by Bausch And Lomb, Epic Pharma Llc, Sandoz, and Somerset Theraps Llc, and is included in four NDAs. It is available from nine suppliers. Additional details are available on the TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE profile page.
The generic ingredient in TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
The generic ingredient in TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
Summary for 211572
| Tradename: | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | polymyxin b sulfate; trimethoprim sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211572
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | polymyxin b sulfate; trimethoprim sulfate | SOLUTION/DROPS;OPHTHALMIC | 211572 | ANDA | Somerset Therapeutics, LLC | 70069-311 | 70069-311-01 | 1 BOTTLE in 1 CARTON (70069-311-01) / 10 mL in 1 BOTTLE |
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | polymyxin b sulfate; trimethoprim sulfate | SOLUTION/DROPS;OPHTHALMIC | 211572 | ANDA | REMEDYREPACK INC. | 70518-4381 | 70518-4381-0 | 1 BOTTLE in 1 CARTON (70518-4381-0) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 10,000 UNITS/ML;EQ 1MG BASE/ML | ||||
| Approval Date: | Aug 5, 2024 | TE: | AT | RLD: | No | ||||
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