Application 213266
- 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 |
|---|
| 58602-835 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-835 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-835 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-836 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-836 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-836 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-903 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-904 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-905 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |
| 58602-906 | NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | ANDA | Current |