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Application 091404
- Type
- ANDA
- Sponsor
- ACS DOBFAR
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEROPENEM | MEROPENEM | INJECTABLE;INJECTION | 500MG/VIAL | No | No |
| 002 | MEROPENEM | MEROPENEM | INJECTABLE;INJECTION | 1GM/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-0222 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1390 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1390 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1390 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1390 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1391 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1391 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1391 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-1391 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 0409-3412 | Meropenem | Meropenem | Hospira, Inc. | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-507 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-508 | Meropenem | Meropenem | Fresenius Kabi USA, LLC | ANDA | Current |