Details for New Drug Application (NDA): 201406
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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. Twelve suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.
Summary for 201406
Tradename: | AMPICILLIN AND SULBACTAM |
Applicant: | Antibiotice |
Ingredient: | ampicillin sodium; sulbactam sodium |
Patents: | 0 |
Pharmacology for NDA: 201406
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 201406
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 201406 | ANDA | WG Critical Care, LLC | 44567-150 | 44567-150-10 | 10 VIAL in 1 CARTON (44567-150-10) / 20 mL in 1 VIAL |
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 201406 | ANDA | Methapharm, Inc. | 67850-130 | 67850-130-10 | 10 VIAL, GLASS in 1 CARTON (67850-130-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | ||||
Approval Date: | Dec 7, 2015 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | ||||
Approval Date: | Dec 7, 2015 | TE: | AP | RLD: | No |
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