Application 076438
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0406-8320 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8320 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8320 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8320 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8320 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8390 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8390 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8390 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8390 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
| 0406-8390 | MORPHINE SULFATE | MORPHINE SULFATE | SpecGx LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44529 | ORIG | 2015-06-30 |