Application 078761
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 004 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 005 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55700-824 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-824 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-824 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 63304-450 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-450 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-450 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-451 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-451 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-451 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-452 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-452 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-452 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-453 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-453 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-453 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-758 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-758 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-758 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-1087 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1087 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1087 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1088 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1088 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1088 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1089 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1089 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1089 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1090 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1090 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1090 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0676 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0676 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0676 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0707 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0707 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0707 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0736 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0736 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0736 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24063 | ORIG | 2015-03-24 |