Orange Book product
DICYCLOMINE HYDROCHLORIDE 10MG
Orange Book ANDA 217531 · PRINSTON PHARMACEUTICAL INC · Prescription
Key facts
| Proprietary name | DICYCLOMINE HYDROCHLORIDE |
|---|---|
| Active ingredients | DICYCLOMINE HYDROCHLORIDE |
| Strength | 10MG |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA217531 |
| Applicant holder | PRINSTON PHARMACEUTICAL INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 30, 2023 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.