Application 020868
- Type
- NDA
- Sponsor
- GD SEARLE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLAGYL ER | METRONIDAZOLE | TABLET, EXTENDED RELEASE;ORAL | 750MG | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79025 | SUPPL | 2024-07-09 |
| 79010 | SUPPL | 2024-07-09 |
| 75699 | SUPPL | 2023-10-10 |
| 75686 | SUPPL | 2023-10-10 |
| 69678 | SUPPL | 2021-12-20 |
| 69611 | SUPPL | 2021-12-17 |
| 66690 | SUPPL | 2021-03-09 |
| 66665 | SUPPL | 2021-03-09 |
| 53625 | SUPPL | 2018-04-05 |
| 53603 | SUPPL | 2018-04-04 |
| 35538 | SUPPL | 2015-07-16 |
| 26085 | SUPPL | 2015-07-14 |
| 35537 | SUPPL | 2013-08-21 |
| 26084 | SUPPL | 2013-08-20 |
| 3618 | SUPPL | 2010-08-24 |
| 13647 | SUPPL | 2010-08-20 |
| 35536 | SUPPL | 2004-04-05 |
| 26083 | SUPPL | 2004-03-24 |
| 3617 | SUPPL | 2003-05-29 |
| 13646 | SUPPL | 2003-04-28 |
| 21033 | ORIG | 1997-11-26 |