Drugs@FDA: FDA-Approved Drugs
Company: TARO PHARM INDS
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 |
---|---|---|---|---|---|---|---|
09/18/2001 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75788TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75788ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/27/2022 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
04/14/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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05/24/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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05/24/2016 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
02/13/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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11/04/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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07/05/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
10/30/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/26/2008 | SUPPL-3 | 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 |