Application 091693
- Type
- ANDA
- Sponsor
- DR REDDYS LABS SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RAMELTEON | RAMELTEON | TABLET;ORAL | 8MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-741 | Ramelteon | Ramelteon | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-741 | Ramelteon | Ramelteon | Dr.Reddys Laboratories Inc | ANDA | Current |
| 50268-708 | Ramelteon | Ramelteon | AvPAK | ANDA | Current |
| 50268-708 | Ramelteon | Ramelteon | AvPAK | ANDA | Current |
| 50268-708 | Ramelteon | Ramelteon | AvPAK | ANDA | Current |
| 51407-375 | Ramelteon | Ramelteon | Golden State Medical Supply | ANDA | Current |
| 51407-375 | Ramelteon | Ramelteon | Golden State Medical Supply, Inc. | ANDA | Current |