Orange Book product · Brand (NDA)
VASERETIC
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
At a glance
Jul 12, 1995
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 12, 1995
31 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
Strength
5MG;12.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019221
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2004ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076486 · MPP PHARMA
- 2003ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075736 · IVAX SUB TEVA PHARMS
- 2001ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075909 · SENORES PHARMS
- 2001ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076116 · CHARTWELL RX
- 2001ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075727 · COSETTE
- 2001ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075624 · RISING
- 2001ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075788 · TARO PHARM INDS
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.
