Application 040349
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SULFASALAZINE | SULFASALAZINE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0603-5801 | Sulfasalazine | sulfasalazine | Par Pharmaceutical | ANDA | Current |
| 10544-288 | Sulfasalazine | sulfasalazine | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-756 | Sulfasalazine | sulfasalazine | Aidarex Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22131 | ORIG | 2005-07-22 |