Application 076045
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 0.5MG | No | No |
| 002 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 1MG | No | No |
| 003 | LORAZEPAM | LORAZEPAM | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10544-085 | Lorazepam | Lorazepam | Blenheim Pharmacal, Inc. | ANDA | Current |
| 12634-867 | Lorazepam | Lorazepam | Apotheca, Inc | ANDA | Current |
| 33358-221 | Lorazepam | Lorazepam | RxChange Co. | ANDA | Current |
| 63304-772 | Lorazepam | Lorazepam | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-773 | Lorazepam | Lorazepam | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-774 | Lorazepam | Lorazepam | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 64725-0772 | Lorazepam | Lorazepam | TYA Pharmaceuticals | ANDA | Current |
| 64725-0773 | Lorazepam | Lorazepam | TYA Pharmaceuticals | ANDA | Current |
| 68788-9839 | Lorazepam | Lorazepam | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-9840 | Lorazepam | Lorazepam | Preferred Pharmaceuticals, Inc | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8855 | ORIG | 2003-04-15 |