Application 050797
- Type
- NDA
- Sponsor
- PF PRISM CV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZMAX | AZITHROMYCIN | FOR SUSPENSION, EXTENDED RELEASE;ORAL | EQ 2GM BASE/BOT | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-444 | Zmax | azithromycin | Rebel Distributors Corp | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69396 | SUPPL | 2021-11-23 |
| 69387 | SUPPL | 2021-11-23 |
| 58416 | SUPPL | 2019-04-25 |
| 58405 | SUPPL | 2019-04-24 |
| 47840 | SUPPL | 2017-04-03 |
| 47795 | SUPPL | 2017-03-31 |
| 47186 | SUPPL | 2017-02-13 |
| 47170 | SUPPL | 2017-02-10 |
| 8318 | SUPPL | 2016-05-26 |
| 39363 | SUPPL | 2016-05-25 |
| 8317 | SUPPL | 2015-07-10 |
| 39362 | SUPPL | 2015-07-06 |
| 39360 | SUPPL | 2013-10-17 |
| 30585 | SUPPL | 2013-10-15 |
| 44210 | ORIG | 2013-03-12 |
| 30588 | SUPPL | 2013-02-21 |
| 18283 | SUPPL | 2013-02-21 |
| 18282 | SUPPL | 2012-03-06 |
| 30587 | SUPPL | 2012-03-05 |
| 39361 | SUPPL | 2011-09-20 |
| 18281 | SUPPL | 2011-09-20 |
| 18280 | SUPPL | 2011-09-20 |
| 30586 | SUPPL | 2011-06-10 |
| 30584 | SUPPL | 2011-06-10 |
| 8316 | SUPPL | 2011-06-10 |
| 18279 | SUPPL | 2008-10-09 |
| 8315 | SUPPL | 2008-10-09 |
| 8314 | SUPPL | 2007-11-08 |
| 39359 | SUPPL | 2007-11-07 |
| 42744 | ORIG | 2007-09-10 |
| 30583 | ORIG | 2005-06-14 |
| 18278 | ORIG | 2005-06-14 |
| 53182 | SUPPL | 1900-01-01 |
| 53181 | SUPPL | 1900-01-01 |