Orange Book product
IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG
Orange Book ANDA 203500 · DR REDDYS LABORATORIES LTD · Prescription
Key facts
| Proprietary name | IRBESARTAN AND HYDROCHLOROTHIAZIDE |
|---|---|
| Active ingredients | HYDROCHLOROTHIAZIDE, IRBESARTAN |
| Strength | 12.5MG;300MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA203500 |
| Applicant holder | DR REDDYS LABORATORIES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 27, 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.