Application 062719
- Type
- ANDA
- Sponsor
- ISTITUTO BIO ITA SPA
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | No | No |
| 002 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 003 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1595 | AMPICILLIN | AMPICILLIN | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1595 | AMPICILLIN | AMPICILLIN | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 63323-387 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-387 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-388 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-388 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-389 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-389 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-014 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-014 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-014 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-014 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-014 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-016 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-016 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-016 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-016 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-016 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-018 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-018 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-018 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-018 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-018 | Ampicillin | ampicillin sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 72572-016 | AMPICILLIN | Ampicillin | Civica, Inc. | ANDA | Current |
| 72572-016 | AMPICILLIN | Ampicillin | Civica, Inc. | ANDA | Current |
| 72572-016 | AMPICILLIN | Ampicillin | Civica, Inc. | ANDA | Current |
| 72572-017 | AMPICILLIN | Ampicillin | Civica, Inc. | ANDA | Current |