Orange Book product · Generic (ANDA)
ENALAPRIL MALEATE
ENALAPRIL MALEATE
At a glance
Aug 10, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 10, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ENALAPRIL MALEATE
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AB
Application
ANDA 212408
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 218531 · UNIQUE PHARM
- 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
- 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.
