Orange Book product
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE
Orange Book ANDA 079229 · ORBION PHARMACEUTICALS PRIVATE LTD · Prescription
Key facts
| Proprietary name | ROPINIROLE HYDROCHLORIDE |
|---|---|
| Active ingredients | ROPINIROLE HYDROCHLORIDE |
| Strength | EQ 4MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA079229 |
| Applicant holder | ORBION PHARMACEUTICALS PRIVATE LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 28, 2012 |
At a glance
- 1–9 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.