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Application 203046
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CODEINE SULFATE | CODEINE SULFATE | TABLET;ORAL | 15MG | No | No |
| 002 | CODEINE SULFATE | CODEINE SULFATE | TABLET;ORAL | 30MG | No | No |
| 003 | CODEINE SULFATE | CODEINE SULFATE | TABLET;ORAL | 60MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0527-1698 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1698 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1698 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1698 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1699 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1699 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1699 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1699 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1727 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
| 0527-1727 | Codeine Sulfate | Codeine Sulfate | Lannett Company, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76089 | ORIG | 2023-11-02 |