Application 205634
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
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 |
|---|
| 57664-190 | Morphine Sulfate Extended-Release | Morphine Sulfate Extended-Release | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-191 | Morphine Sulfate Extended-Release | Morphine Sulfate Extended-Release | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-192 | Morphine Sulfate Extended-Release | Morphine Sulfate Extended-Release | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-196 | Morphine Sulfate Extended-Release | Morphine Sulfate Extended-Release | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-197 | Morphine Sulfate Extended-Release | Morphine Sulfate Extended-Release | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76293 | ORIG | 2023-11-03 |
| 45820 | APPL | 2016-11-04 |