Application 212983
- Type
- ANDA
- Sponsor
- DR REDDYS LABS SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 2MG BASE | No | No |
| 002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 4MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-484 | Nicotine Polacrilex | Nicotine Polacrilex | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-485 | Nicotine Polacrilex | Nicotine Polacrilex | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-982 | Habitrol Lozenge | Nicotine Polacrilex | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-983 | Habitrol Lozenge | Nicotine Polacrilex | Dr. Reddy's Laboratories Inc. | ANDA | Current |