Details for New Drug Application (NDA): 090579
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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 090579
Tradename: | AMPICILLIN AND SULBACTAM |
Applicant: | Astral |
Ingredient: | ampicillin sodium; sulbactam sodium |
Patents: | 0 |
Pharmacology for NDA: 090579
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 090579
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090579 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-081 | 70594-081-02 | 10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01) |
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090579 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-082 | 70594-082-02 | 10 VIAL in 1 CARTON (70594-082-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-082-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | ||||
Approval Date: | Jan 8, 2016 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | ||||
Approval Date: | Jan 8, 2016 | TE: | RLD: | No |
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