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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075788
Company: TARO PHARM INDS

Products on ANDA 075788

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075788

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.
05/24/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
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.
11/04/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
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.
11/26/2008	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075788

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

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