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Application 211454
- Type
- ANDA
- Sponsor
- WINDER LABS LLC
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 | 20MG/5ML | No | No |
| 003 | 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 |
|---|
| 75826-129 | Morphine Sulfate | Morphine Sulfate | Winder Laboratories LLC | ANDA | Current |
| 75826-129 | Morphine Sulfate | Morphine Sulfate | Winder Laboratories LLC | ANDA | Current |
| 75826-130 | Morphine Sulfate | Morphine Sulfate | Winder Laboratories LLC | ANDA | Current |
| 75826-130 | Morphine Sulfate | Morphine Sulfate | Winder Laboratories LLC | ANDA | Current |
| 75826-131 | Morphine Sulfate | Morphine Sulfate | Winder Laboratories LLC | ANDA | Current |
| 75826-131 | Morphine Sulfate | Morphine Sulfate | Winder Laboratories LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76468 | ORIG | 2023-11-07 |