Application 075416
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NAPROXEN SODIUM | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG BASE | No | No |
| 002 | NAPROXEN SODIUM | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 375MG BASE | No | No |
| 003 | NAPROXEN SODIUM | NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 750MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0480-0951 | Naproxen Sodium | naproxen sodium | Teva Pharmaceuticals, Inc. | ANDA | Current |
| 0480-0952 | Naproxen sodium | naproxen sodium | Teva Pharmaceuticals, Inc. | ANDA | Current |
| 0480-0953 | Naproxen Sodium | naproxen sodium | Teva Pharmaceuticals, Inc. | ANDA | Current |
| 62037-825 | Naproxen Sodium | naproxen sodium | Actavis Pharma, Inc. | ANDA | Current |
| 62037-825 | Naproxen Sodium | naproxen sodium | Actavis Pharma, Inc. | ANDA | Current |
| 62037-825 | Naproxen Sodium | naproxen sodium | Actavis Pharma, Inc. | ANDA | Current |
| 62037-826 | Naproxen Sodium | naproxen sodium | Actavis Pharma, Inc. | ANDA | Current |
| 62037-826 | Naproxen Sodium | naproxen sodium | Actavis Pharma, Inc. | ANDA | Current |
| 62037-826 | Naproxen Sodium | naproxen sodium | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22471 | ORIG | 2014-08-01 |