Drug application
VARENICLINE TARTRATE (VARENICLINE TARTRATE)
Drugs@FDA ANDA 201785 · PH HEALTH
Key facts
| Drug name | VARENICLINE TARTRATE |
|---|---|
| Active ingredients | VARENICLINE TARTRATE |
| Application type | ANDA |
| Application number | 201785 |
| Company | PH HEALTH |
| Dosage forms | TABLET, ORAL |
| Strength | EQ 0.5MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission class | Not Applicable |
| Latest submission status date | Aug 11, 2021 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 10–99 Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: