Details for New Drug Application (NDA): 202198
The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 202198
| Tradename: | AMPICILLIN SODIUM |
| Applicant: | Onesource Specialty |
| Ingredient: | ampicillin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202198
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 202198 | ANDA | Armas Pharmaceuticals Inc. | 72485-423 | 72485-423-10 | 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (72485-423-10) |
| AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 202198 | ANDA | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-315 | 83270-315-01 | 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (83270-315-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Apr 7, 2014 | TE: | AP | RLD: | No | ||||
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