Drug application
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
Drugs@FDA ANDA 214721 · NOVITIUM PHARMA
Key facts
| Drug name | DICYCLOMINE HYDROCHLORIDE |
|---|---|
| Active ingredients | DICYCLOMINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 214721 |
| Company | NOVITIUM PHARMA |
| Dosage forms | SYRUP, ORAL |
| Strength | 10MG/5ML |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Apr 23, 2021 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 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.