DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 065006
NDA 065006 describes TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, which is a drug marketed by Akorn Inc, Bausch And Lomb, and Sandoz Inc, and is included in three NDAs. It is available from fifteen 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. Twenty 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. 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 | ||||
Complete Access Available with Subscription
