FDA Orange Book · active-ingredient family
Enalapril maleate; hydrochlorothiazide
Enalapril maleate; hydrochlorothiazide is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VASERETIC · NDA 019221
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VASERETICRLD×2 | BAUSCH | NDA 019221 | AB | Jul 12, 1995 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE×2 | MPP PHARMA | ANDA 076486 | — | Oct 27, 2004 | |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE×2 | IVAX SUB TEVA PHARMS | ANDA 075736 | — | Mar 25, 2003 | |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE×2 | SENORES PHARMS | ANDA 075909 | AB | Oct 15, 2001 | |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE×2 | CHARTWELL RX | ANDA 076116 | — | Sep 19, 2001 | |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE×2 | COSETTE | ANDA 075727 | — | Sep 18, 2001 | |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE×2 | RISING | ANDA 075624 | — | Sep 18, 2001 | |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE×2 | TARO PHARM INDS | ANDA 075788 | AB | Sep 18, 2001 |
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.
Enalapril maleate; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
