Details for New Drug Application (NDA): 065022
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NDA 065022 describes BACITRACIN ZINC AND POLYMYXIN B SULFATE, which is a drug marketed by Bausch And Lomb, Padagis Us, and Sciegen Pharms Inc, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the BACITRACIN ZINC AND POLYMYXIN B SULFATE profile page.
The generic ingredient in BACITRACIN ZINC AND POLYMYXIN B SULFATE is bacitracin zinc; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.
The generic ingredient in BACITRACIN ZINC AND POLYMYXIN B SULFATE is bacitracin zinc; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.
Summary for 065022
| Tradename: | BACITRACIN ZINC AND POLYMYXIN B SULFATE |
| Applicant: | Padagis Us |
| Ingredient: | bacitracin zinc; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 065022
| Physiological Effect | Decreased Cell Wall Synthesis & Repair |
Suppliers and Packaging for NDA: 065022
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | bacitracin zinc; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 065022 | ANDA | Padagis US LLC | 0574-4021 | 0574-4021-35 | 1 TUBE in 1 CARTON (0574-4021-35) / 3.5 g in 1 TUBE |
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | bacitracin zinc; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 065022 | ANDA | RPK Pharmaceuticals, Inc. | 53002-9270 | 53002-9270-1 | 3.5 g in 1 TUBE (53002-9270-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 500 UNITS/GM;10,000 UNITS/GM | ||||
| Approval Date: | Feb 27, 2002 | TE: | AT | RLD: | No | ||||
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