Application 205386
- Type
- ANDA
- Sponsor
- MAYNE PHARMA INC
Application Products#
| 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-185 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-185 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-185 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-186 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-186 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-186 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-187 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-187 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-187 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-188 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-188 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
| 51862-188 | Morphine Sulfate | Morphine Sulfate | Mayne Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46808 | ORIG | 2017-01-13 |