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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075909
Company: DR REDDYS LABS LTD

Products on ANDA 075909

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 075909

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.

Labels for ANDA 075909

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2001	ORIG-1	Approval			https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-909_Enalapril%20Maleate%20and%20Hydrochlorothiazide_Prntlb

Therapeutic Equivalents for ANDA 075909

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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