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Application 203518
- Type
- ANDA
- Sponsor
- TRIS PHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;ORAL | 10MG/5ML | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;ORAL | 100MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-082 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-084 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-084 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-084 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-084 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 27808-084 | Morphine Sulfate | Morphine Sulfate | Tris Pharma Inc | ANDA | Current |
| 63629-2301 | Morphine Sulfate | Morphine Sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-2301 | Morphine Sulfate | Morphine Sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-2301 | Morphine Sulfate | Morphine Sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-2302 | Morphine Sulfate | Morphine Sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-2302 | Morphine Sulfate | Morphine Sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-2302 | Morphine Sulfate | Morphine Sulfate | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76148 | ORIG | 2023-11-03 |
| 32437 | ORIG | 2015-05-19 |