Application 020353
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPRELAN | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 375MG BASE | Yes | No |
| 002 | NAPRELAN | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG BASE | Yes | No |
| 003 | NAPRELAN | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 750MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-905 | NAPRELAN | naproxen sodium | Rebel Distributors Corp | NDA | Current |
| 21695-906 | NAPRELAN | naproxen sodium | Rebel Distributors Corp | NDA | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-153 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-154 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-155 | Naproxen Sodium | Naproxen Sodium | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | Almatica Pharma LLC | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-272 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | Almatica Pharma LLC | NDA | Current |
| 52427-273 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | Almatica Pharma LLC | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 52427-274 | Naprelan | Naproxen Sodium | ALMATICA PHARMA INC. | NDA | Current |
| 59630-375 | Naprelan | Naproxen Sodium | Shionogi Inc. | NDA | Current |
| 59630-777 | Naprelan | Naproxen Sodium | Shionogi Inc. | NDA | Current |
| 59630-850 | Naprelan | Naproxen Sodium | Shionogi Inc. | NDA | Current |
| 69420-1375 | Naproxen Sodium | Naproxen Sodium | SA3, LLC | NDA AUTHORIZED GENERIC | Current |
| 71800-020 | Naproxen Sodium | Naproxen Sodium | Innovida Phamaceutique Corporation | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80346 | SUPPL | 2024-11-25 |
| 80324 | SUPPL | 2024-11-22 |
| 80323 | SUPPL | 2024-11-22 |
| 67348 | SUPPL | 2021-05-03 |
| 67347 | SUPPL | 2021-05-03 |
| 67254 | SUPPL | 2021-04-29 |
| 59421 | SUPPL | 2019-07-23 |
| 59420 | SUPPL | 2019-07-23 |
| 59410 | SUPPL | 2019-07-23 |
| 49724 | SUPPL | 2017-09-13 |
| 2365 | SUPPL | 2016-05-12 |
| 2364 | SUPPL | 2016-05-12 |
| 34532 | SUPPL | 2016-05-11 |
| 12465 | SUPPL | 2016-05-11 |
| 43644 | ORIG | 2011-11-17 |
| 24809 | SUPPL | 2011-11-10 |
| 34531 | SUPPL | 2011-11-09 |
| 34530 | SUPPL | 2009-11-06 |
| 2363 | SUPPL | 2009-08-10 |
| 24808 | SUPPL | 2007-06-04 |
| 34529 | SUPPL | 2006-01-20 |
| 24807 | SUPPL | 2006-01-20 |
| 20601 | SUPPL | 2003-08-08 |