Drug application
ABACAVIR SULFATE (ABACAVIR SULFATE)
Drugs@FDA ANDA 201107 · HETERO LABS LTD III
Key facts
| Drug name | ABACAVIR SULFATE |
|---|---|
| Active ingredients | ABACAVIR SULFATE |
| Application type | ANDA |
| Application number | 201107 |
| Company | HETERO LABS LTD III |
| Dosage forms | SOLUTION, ORAL |
| Strength | EQ 20MG BASE/ML |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission class | Not Applicable |
| Latest submission status date | Sep 26, 2016 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- 1–9 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: