Drug application
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE)
Drugs@FDA ANDA 210819 · UNICHEM
Key facts
| Drug name | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
|---|---|
| Active ingredients | ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 210819 |
| Company | UNICHEM |
| Dosage forms | TABLET, ORAL |
| Strength | 0.025MG;2.5MG |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Nov 13, 2018 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 10–99 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.