Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213273
Company: PRINSTON INC
Company: PRINSTON INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/07/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ENALAPRIL MALEATE
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075496 | SANDOZ INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 218531 | UNIQUE PHARM |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
VASOTEC | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075496 | SANDOZ INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 218531 | UNIQUE PHARM |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
VASOTEC | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075459 | SANDOZ INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 218531 | UNIQUE PHARM |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
VASOTEC | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075459 | SANDOZ INC |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 218531 | UNIQUE PHARM |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
VASOTEC | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |