Details for New Drug Application (NDA): 065006
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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 065006
Tradename: | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE |
Applicant: | Epic Pharma Llc |
Ingredient: | polymyxin b sulfate; trimethoprim sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 065006
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 | 065006 | ANDA | Proficient Rx LP | 63187-193 | 63187-193-10 | 1 BOTTLE, DROPPER in 1 CARTON (63187-193-10) / 10 mL in 1 BOTTLE, DROPPER |
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: | Dec 17, 1998 | TE: | AT | RLD: | No |
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