FDA Orange Book · active-ingredient family
Hydrochlorothiazide; irbesartan
Hydrochlorothiazide; irbesartan is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AVALIDE · NDA 020758
1
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AVALIDERLD×4 | SANOFI AVENTIS US | NDA 020758 | — | Sep 30, 1997 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | UNICHEM | ANDA 207018 | — | Sep 19, 2017 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | HISUN PHARM HANGZHOU | ANDA 207896 | AB | Oct 14, 2016 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×3 | ATLAS PHARMS LLC | ANDA 203036 | — | Jan 15, 2016 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | PRINSTON INC | ANDA 203072 | AB | May 09, 2014 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | CHARTWELL RX | ANDA 201524 | — | Feb 27, 2013 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×3 | AUROBINDO PHARMA LTD | ANDA 203630 | AB | Feb 22, 2013 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | WATSON LABS INC | ANDA 091539 | — | Oct 22, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×3 | ALEMBIC | ANDA 091370 | AB | Oct 15, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | APOTEX INC | ANDA 201505 | — | Oct 15, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×3 | HIKMA | ANDA 090351 | AB | Oct 15, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | DR REDDYS LABS LTD | ANDA 203500 | AB | Sep 27, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | MACLEODS PHARMS LTD | ANDA 202414 | AB | Sep 27, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×3 | PHARMOBEDIENT | ANDA 077969 | — | Sep 27, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×2 | SANDOZ | ANDA 077446 | AB | Sep 27, 2012 | |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE×3 | TEVA | ANDA 077369 | AB | Mar 30, 2012 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydrochlorothiazide; irbesartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
