Application 018900
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METRO I.V. IN PLASTIC CONTAINER | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-5535 | METRONIDAZOLE | METRONIDAZOLE | B. Braun Medical Inc. | NDA | Current |
| 0264-5535 | METRONIDAZOLE | METRONIDAZOLE | B. Braun Medical Inc. | NDA | Current |
| 0264-5535 | METRONIDAZOLE | METRONIDAZOLE | B. Braun Medical Inc. | NDA | Current |
| 0264-5535 | METRONIDAZOLE | METRONIDAZOLE | B. Braun Medical Inc. | NDA | Current |
| 55154-5175 | METRONIDAZOLE | METRONIDAZOLE | Cardinal Health | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85754 | SUPPL | 2026-04-27 |
| 85743 | SUPPL | 2026-04-24 |
| 81619 | SUPPL | 2025-03-18 |
| 81612 | SUPPL | 2025-03-17 |
| 79020 | SUPPL | 2024-07-09 |
| 79007 | SUPPL | 2024-07-09 |
| 69673 | SUPPL | 2021-12-20 |
| 69606 | SUPPL | 2021-12-17 |
| 67305 | SUPPL | 2021-04-30 |
| 67263 | SUPPL | 2021-04-30 |
| 66693 | SUPPL | 2021-03-09 |
| 66668 | SUPPL | 2021-03-09 |
| 53687 | SUPPL | 2018-04-16 |
| 53662 | SUPPL | 2018-04-12 |
| 33638 | SUPPL | 2015-12-10 |
| 1123 | SUPPL | 2015-12-10 |
| 33639 | SUPPL | 2015-07-16 |
| 1124 | SUPPL | 2015-07-14 |