Application 075855
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXAPROZIN | OXAPROZIN | TABLET;ORAL | 600MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-2012 | Oxaprozin | Oxaprozin | A-S Medication Solutions | ANDA | Current |
| 52959-800 | Oxaprozin | Oxaprozin | H.J. Harkins Company, Inc. | ANDA | Current |
| 55111-170 | Oxaprozin | Oxaprozin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-170 | Oxaprozin | Oxaprozin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-170 | Oxaprozin | Oxaprozin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 60760-382 | Oxaprozin | Oxaprozin | ST MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 70332-310 | OXAPROZIN | OXAPROZIN | California Pharmaceuticals LLC | ANDA | Current |
| 71335-0393 | Oxaprozin | Oxaprozin | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8811 | ORIG | 2001-01-31 |