Details for New Drug Application (NDA): 064211
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NDA 064211 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 eleven 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
Summary for 064211
| Tradename: | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
| Applicant: | Sandoz |
| Ingredient: | polymyxin b sulfate; trimethoprim sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 064211
| 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 | 064211 | ANDA | A-S Medication Solutions | 50090-2925 | 50090-2925-0 | 10 mL in 1 BOTTLE, PLASTIC (50090-2925-0) |
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | polymyxin b sulfate; trimethoprim sulfate | SOLUTION/DROPS;OPHTHALMIC | 064211 | ANDA | RPK Pharmaceuticals, Inc. | 53002-8621 | 53002-8621-1 | 10 mL in 1 BOTTLE, DROPPER (53002-8621-1) |
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: | Apr 13, 1998 | TE: | AT | RLD: | No | ||||
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