Application 062797
- Type
- ANDA
- Sponsor
- ISTITUTO BIO ITA SPA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL | No | No |
| 002 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-399 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-399 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-020 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-020 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-020 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-020 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-020 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 72572-017 | AMPICILLIN | Ampicillin | Civica, Inc. | ANDA | Current |
| 72572-017 | AMPICILLIN | Ampicillin | Civica, Inc. | ANDA | Current |