Orange Book product
MECLIZINE HYDROCHLORIDE 25MG
Orange Book ANDA 202640 · AUROBINDO PHARMA USA INC · Prescription
Key facts
| Proprietary name | MECLIZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | MECLIZINE HYDROCHLORIDE |
| Strength | 25MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA202640 |
| Applicant holder | AUROBINDO PHARMA USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 17, 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.