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Application 204854
- Type
- ANDA
- Sponsor
- DAEWOONG PHARM CO
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 |
|---|
| 25021-155 | Meropenem | meropenem | Sagent Pharmaceuticals | ANDA | Current |
| 25021-155 | Meropenem | meropenem | Sagent Pharmaceuticals | ANDA | Current |
| 25021-156 | Meropenem | meropenem | Sagent Pharmaceuticals | ANDA | Current |
| 25021-156 | Meropenem | meropenem | Sagent Pharmaceuticals | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-103 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
| 70278-104 | Meropenem | Meropenem | Daewoong America Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10403 | ORIG | 2015-12-22 |