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Details for New Drug Application (NDA): 065006
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. Twenty 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: | Akorn Inc |
Ingredient: | polymyxin b sulfate; trimethoprim sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065006
Ingredient-type | Polymyxins |
Mechanism of Action | Dihydrofolate Reductase Inhibitors Cytochrome P450 2C8 Inhibitors Organic Cation Transporter 2 Inhibitors |
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 | Akorn, Inc. | 17478-703 | N | 17478-703-11 |
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | polymyxin b sulfate; trimethoprim sulfate | SOLUTION/DROPS;OPHTHALMIC | 065006 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 55700-414 | N | 55700-414-10 |
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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