Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075909
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | AB | No | No |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | 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 |
---|---|---|---|---|---|---|---|
10/15/2001 | ORIG-1 | Approval |
Label
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-909_Enalapril%20Maleate%20and%20Hydrochlorothiazide_Prntlb https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75909ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075909_enalapril_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/23/2014 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/30/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
05/25/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 5MG;12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 075909 | DR REDDYS LABS LTD |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 075788 | TARO PHARM INDS |
VASERETIC | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 019221 | BAUSCH |
TABLET;ORAL; 10MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET;ORAL | Prescription | No | AB | 075909 | DR REDDYS LABS LTD |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET;ORAL | Prescription | No | AB | 075788 | TARO PHARM INDS |
VASERETIC | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 019221 | BAUSCH |