Details for New Drug Application (NDA): 061212
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NDA 061212 describes BACITRACIN, which is a drug marketed by Lilly, Padagis Us, Pharmaderm, Pharmafair, Combe, Naska, Apothekernes, Paddock Llc, Bausch And Lomb, Sciegen Pharms Inc, and Altana, and is included in seventeen NDAs. It is available from one supplier. Additional details are available on the BACITRACIN profile page.
The generic ingredient in BACITRACIN is bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate profile page.
The generic ingredient in BACITRACIN is bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 061212
| Tradename: | BACITRACIN |
| Applicant: | Padagis Us |
| Ingredient: | bacitracin |
| Patents: | 0 |
Pharmacology for NDA: 061212
| Physiological Effect | Decreased Cell Wall Synthesis & Repair |
Medical Subject Heading (MeSH) Categories for 061212
Suppliers and Packaging for NDA: 061212
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BACITRACIN | bacitracin | OINTMENT;OPHTHALMIC | 061212 | ANDA | Padagis US LLC | 0574-4022 | 0574-4022-35 | 1 TUBE in 1 CARTON (0574-4022-35) / 3.5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 500 UNITS/GM | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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