FDA Orange Book · active-ingredient family
Hydrochlorothiazide; quinapril hydrochloride
Hydrochlorothiazide; quinapril hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACCURETIC · NDA 020125
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACCURETICRLD×3 | PFIZER PHARMS | NDA 020125 | — | Dec 28, 1999 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3 | APOTEX | ANDA 091524 | — | Mar 12, 2013 | |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3 | INVAGEN PHARMS | ANDA 201356 | — | Apr 20, 2011 | |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3 | SUN PHARM INDS LTD | ANDA 078211 | — | Mar 04, 2009 | |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3 | AUROBINDO PHARMA | ANDA 078450 | AB | Aug 24, 2007 | |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3 | PHARMOBEDIENT | ANDA 077093 | — | Mar 28, 2005 | |
| QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3 | CHARTWELL RX | ANDA 076374 | AB | Mar 31, 2004 |
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; quinapril hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
