Details for New Drug Application (NDA): 065403
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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 065403
Tradename: | AMPICILLIN AND SULBACTAM |
Applicant: | Acs Dobfar |
Ingredient: | ampicillin sodium; sulbactam sodium |
Patents: | 0 |
Pharmacology for NDA: 065403
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 065403
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065403 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6118 | 0641-6118-01 | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065403 | ANDA | West-Ward Pharmaceuticals Corp. | 0641-6121 | 0641-6121-01 | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6121-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | ||||
Approval Date: | Dec 23, 2009 | TE: | AP | RLD: | No |
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