Drug application
IBUPROFEN AND DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE CITRATE, IBUPROFEN)
Drugs@FDA ANDA 216204 · AUROBINDO PHARMA
Key facts
| Drug name | IBUPROFEN AND DIPHENHYDRAMINE CITRATE |
|---|---|
| Active ingredients | DIPHENHYDRAMINE CITRATE, IBUPROFEN |
| Application type | ANDA |
| Application number | 216204 |
| Company | AUROBINDO PHARMA |
| Dosage forms | TABLET, ORAL |
| Strength | 38MG;200MG |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | May 31, 2022 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
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.