Details for New Drug Application (NDA): 090578
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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. Thirteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 090578
Tradename: | AMPICILLIN AND SULBACTAM |
Applicant: | Astral |
Ingredient: | ampicillin sodium; sulbactam sodium |
Patents: | 0 |
Pharmacology for NDA: 090578
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 090578
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090578 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-083 | 70594-083-01 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090578 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-007 | 71288-007-75 | 1 BOTTLE in 1 CARTON (71288-007-75) / 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: | Jan 11, 2016 | TE: | AP | RLD: | No |
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