Application 076658
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 50MG | No | No |
| 002 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 100MG | No | No |
| 003 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 150MG | No | No |
| 004 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6500 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6500 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6500 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6500 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6500 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6501 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6501 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6501 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6501 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6501 | Fluconazole | Fluconazole | Major Pharmaceuticals | ANDA | Current |
| 55111-143 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-143 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-143 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-143 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-144 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-144 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-144 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-144 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-145 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-145 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-145 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-145 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-146 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-146 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-146 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-146 | Fluconazole | Fluconazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55154-3400 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-3400 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-3400 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-7875 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-7875 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-7875 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55700-916 | Fluconazole | Fluconazole | Quality Care Products, LLC | ANDA | Current |
| 61919-380 | Fluconazole | Fluconazole | Direct Rx | ANDA | Current |
| 61919-380 | Fluconazole | Fluconazole | Direct Rx | ANDA | Current |
| 61919-380 | Fluconazole | Fluconazole | Direct Rx | ANDA | Current |
| 68071-3344 | Fluconazole | Fluconazole | Nucare Pharmaceuticals,Inc | ANDA | Current |
| 68788-8938 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9988 | Fluconazole | Fluconazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71335-1448 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1448 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1448 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 72189-143 | FLUCONAZOLE | FLUCONAZOLE | direct rx | ANDA | Current |
| 72189-143 | FLUCONAZOLE | FLUCONAZOLE | direct rx | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8944 | ORIG | 2004-07-30 |