Application 050706
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MERREM | MEROPENEM | INJECTABLE;INJECTION | 1GM/VIAL | Yes | Yes |
| 003 | MERREM | MEROPENEM | INJECTABLE;INJECTION | 500MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0313 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0313 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0313 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0313 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0313 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0314 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0314 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0314 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0314 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0314 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0314 | MERREM | Meropenem | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0310-0321 | MERREM | Meropenem | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0321 | MERREM | Meropenem | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0321 | MERREM | Meropenem | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0325 | MERREM | Meropenem | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0325 | MERREM | Meropenem | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82162 | SUPPL | 2025-05-06 |
| 82263 | SUPPL | 2025-05-02 |
| 80516 | SUPPL | 2024-12-05 |
| 80493 | SUPPL | 2024-12-04 |
| 58471 | SUPPL | 2019-04-30 |
| 58465 | SUPPL | 2019-04-27 |
| 54468 | SUPPL | 2018-06-06 |
| 54460 | SUPPL | 2018-06-05 |
| 51865 | SUPPL | 2018-01-26 |
| 51090 | SUPPL | 2018-01-18 |
| 46669 | SUPPL | 2017-01-05 |
| 46652 | SUPPL | 2017-01-03 |
| 39141 | SUPPL | 2016-07-28 |
| 8045 | SUPPL | 2016-07-28 |
| 39140 | SUPPL | 2015-01-09 |
| 30308 | SUPPL | 2014-12-24 |
| 22192 | SUPPL | 2014-07-07 |
| 39139 | SUPPL | 2013-12-17 |
| 30307 | SUPPL | 2013-12-17 |
| 18050 | SUPPL | 2013-12-17 |
| 8044 | SUPPL | 2013-12-17 |
| 39138 | SUPPL | 2013-04-01 |
| 30306 | SUPPL | 2013-04-01 |
| 30305 | SUPPL | 2010-12-28 |
| 18049 | SUPPL | 2010-12-26 |
| 8043 | SUPPL | 2009-11-20 |
| 18048 | SUPPL | 2009-11-06 |
| 8041 | SUPPL | 2008-04-02 |
| 18046 | SUPPL | 2008-03-27 |
| 18047 | SUPPL | 2008-03-17 |
| 8042 | SUPPL | 2008-03-17 |
| 42682 | SUPPL | 2007-07-20 |
| 8040 | SUPPL | 2005-08-19 |
| 30304 | SUPPL | 2005-05-26 |
| 18045 | SUPPL | 2005-05-26 |
| 8039 | SUPPL | 2004-06-07 |