FDA Orange Book · active-ingredient family
Hydrochlorothiazide; lisinopril
Hydrochlorothiazide; lisinopril is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRINZIDE · NDA 019778
2
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRINZIDERLD×3 | MERCK | NDA 019778 | — | Nov 18, 1993 | |
| ZESTORETICRLD×3 | ALMATICA | NDA 019888 | AB | Nov 18, 1993 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | INVAGEN PHARMS | ANDA 204058 | AB | May 23, 2017 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | LUPIN | ANDA 077912 | AB | Sep 27, 2006 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | AUROBINDO | ANDA 077606 | AB | Mar 14, 2006 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | COREPHARMA | ANDA 076674 | AB | Oct 05, 2004 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | HIKMA INTL PHARMS | ANDA 076265 | — | Jul 08, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | AIPING PHARM INC | ANDA 076262 | AB | Jul 01, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | CHARTWELL RX | ANDA 075776 | — | Jul 01, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | EPIC PHARMA LLC | ANDA 075926 | — | Jul 01, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | PHARMOBEDIENT | ANDA 076113 | — | Jul 01, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | PRINSTON INC | ANDA 076230 | AB | Jul 01, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | SUN PHARM INDS LTD | ANDA 076007 | AB | Jul 01, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | TEVA | ANDA 075869 | — | Jul 01, 2002 | |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE×3 | WATSON LABS | ANDA 076194 | AB | Jul 01, 2002 |
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; lisinopril — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
