Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075496
Company: SANDOZ INC
Company: SANDOZ 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/22/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75459ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/14/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/17/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/01/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/24/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/10/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
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 | 075178 | AIPING PHARM INC |
| 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 | 075483 | SENORES PHARMS |
| 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 |
| 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 | 075178 | AIPING PHARM INC |
| 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 | 075483 | SENORES PHARMS |
| 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 |
| VASOTEC | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |