Application 215357
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 58602-722 | NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | ANDA | Current |
| 58602-723 | NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | ANDA | Current |
| 58602-854 | NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | ANDA | Current |
| 58602-855 | NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | ANDA | Current |
| 82966-001 | NICOTINE | NICOTINE POLACRILEX MINI | BLIP PRODUCTS, INC. | ANDA | Current |
| 82966-002 | NICOTINE | NICOTINE POLACRILEX MINI | BLIP PRODUCTS, INC. | ANDA | Current |