Details for New Drug Application (NDA): 065314
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The generic ingredient in AMPICILLIN AND SULBACTAM is ampicillin sodium; sulbactam sodium. There are seventy drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 065314
Tradename: | AMPICILLIN AND SULBACTAM |
Applicant: | Istituto Bio Ita Spa |
Ingredient: | ampicillin sodium; sulbactam sodium |
Patents: | 0 |
Pharmacology for NDA: 065314
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 065314
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065314 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-033 | 71288-033-75 | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065314 | ANDA | NorthStar Rx, LLC | 72603-444 | 72603-444-10 | 10 BOTTLE in 1 CARTON (72603-444-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | ||||
Approval Date: | Nov 27, 2006 | TE: | AP | RLD: | No |
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