Application 201785
- Type
- ANDA
- Sponsor
- PAR PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VARENICLINE | VARENICLINE | TABLET;ORAL | EQ 0.5MG BASE | No | No |
| 002 | VARENICLINE | VARENICLINE | TABLET;ORAL | EQ 1MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49884-155 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-155 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-155 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-155 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-156 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-156 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-156 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-156 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-944 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-944 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-944 | Varenicline | varenicline tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 60687-648 | Varenicline | varenicline tartrate | American Health Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68518 | ORIG | 2021-09-02 |