Drug application
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE)
Drugs@FDA ANDA 087708 · HIKMA PHARMS
Key facts
| Drug name | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
|---|---|
| Active ingredients | ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 087708 |
| Company | HIKMA PHARMS |
| Dosage forms | SOLUTION, ORAL |
| Strength | 0.025MG/5ML;2.5MG/5ML |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission status date | May 3, 1982 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 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.