Application 020067
- Type
- NDA
- Sponsor
- ATNAHS PHARMA US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | EC-NAPROSYN | NAPROXEN | TABLET, DELAYED RELEASE;ORAL | 375MG | Yes | Yes |
| 003 | EC-NAPROSYN | NAPROXEN | TABLET, DELAYED RELEASE;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0004-6415 | EC-Naprosyn | naproxen | Genentech, Inc. | NDA | Current |
| 42494-407 | EC-NAPROXEN | naproxen | Cameron Pharmaceuticals, LLC | NDA | Current |
| 42494-408 | EC-NAPROXEN | naproxen | Cameron Pharmaceuticals, LLC | NDA | Current |
| 63629-2484 | EC-NAPROXEN | naproxen | Bryant Ranch Prepack | NDA | Current |
| 63629-2484 | EC-NAPROXEN | naproxen | Bryant Ranch Prepack | NDA | Current |
| 69437-415 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69437-415 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69437-415 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69437-415 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69437-416 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69437-416 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69437-416 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69437-416 | EC-Naprosyn | naproxen | Canton Laboratories | NDA | Current |
| 69784-500 | EC-NAPROXEN | naproxen | Woodward Pharma Services LLC | NDA | Current |
| 69784-500 | EC-NAPROXEN | naproxen | Woodward Pharma Services LLC | NDA | Current |
| 69784-500 | EC-NAPROXEN | naproxen | Woodward Pharma Services LLC | NDA | Current |
| 69784-501 | EC-NAPROXEN | naproxen | Woodward Pharma Services LLC | NDA | Current |
| 69784-501 | EC-NAPROXEN | naproxen | Woodward Pharma Services LLC | NDA | Current |
| 69784-501 | EC-NAPROXEN | naproxen | Woodward Pharma Services LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80353 | SUPPL | 2024-11-25 |
| 80295 | SUPPL | 2024-11-22 |
| 80294 | SUPPL | 2024-11-22 |
| 78461 | SUPPL | 2024-05-14 |
| 78460 | SUPPL | 2024-05-14 |
| 67283 | SUPPL | 2021-04-30 |
| 67282 | SUPPL | 2021-04-30 |
| 67238 | SUPPL | 2021-04-29 |
| 59431 | SUPPL | 2019-07-23 |
| 59430 | SUPPL | 2019-07-23 |
| 59416 | SUPPL | 2019-07-23 |
| 47561 | SUPPL | 2017-03-14 |
| 47535 | SUPPL | 2017-03-13 |
| 34231 | SUPPL | 2016-05-11 |
| 1982 | SUPPL | 2016-05-11 |
| 12176 | SUPPL | 2013-03-26 |
| 1981 | SUPPL | 2013-03-26 |
| 21101 | SUPPL | 2008-07-30 |
| 12175 | SUPPL | 2008-07-29 |
| 12174 | SUPPL | 2007-09-26 |
| 1980 | SUPPL | 2007-09-25 |
| 1979 | SUPPL | 2007-04-25 |
| 1977 | SUPPL | 2006-03-23 |
| 34230 | SUPPL | 2006-03-14 |
| 1978 | SUPPL | 2006-01-30 |
| 12173 | SUPPL | 2006-01-25 |
| 34229 | SUPPL | 2004-11-16 |
| 21100 | SUPPL | 2004-11-16 |
| 12172 | SUPPL | 2004-11-16 |
| 1975 | SUPPL | 2004-11-16 |
| 1976 | SUPPL | 2003-06-08 |