Application 207108
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1873 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76457 | ORIG | 2023-11-07 |