Orange Book product · Generic (ANDA)
ENALAPRIL MALEATE
ENALAPRIL MALEATE
At a glance
Sep 19, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 2024
1 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ENALAPRIL MALEATE
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 218531
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ENALAPRIL MALEATE
- 2016EPANEDBrand (NDA)
NDA 208686 · AZURITY
- 2013EPANED KITBrand (NDA)
NDA 204308 · AZURITY
- 1988VASOTECBrand (NDA)
NDA 018998 · BAUSCH
- 2024ENALAPRIL MALEATEGeneric (ANDA)
ANDA 216458 · AUROBINDO PHARMA
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 213273 · PRINSTON INC
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 212894 · AMNEAL
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 213714 · ALKEM LABS LTD
- 2022ENALAPRIL MALEATEGeneric (ANDA)
ANDA 214467 · ANNORA PHARMA
- 2021ENALAPRIL MALEATEGeneric (ANDA)
ANDA 212408 · BIONPHARMA
- 2001ENALAPRIL MALEATEGeneric (ANDA)
ANDA 075178 · AIPING PHARM INC
- 2001ENALAPRIL MALEATEGeneric (ANDA)
ANDA 075657 · TARO
- 2000ENALAPRIL MALEATEGeneric (ANDA)
ANDA 075583 · APOTHECON
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.
