Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077690
Company: LUPIN

• Other Important Information from FDA

Products on ANDA 077690

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077690

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2018	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
07/19/2018	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
02/18/2016	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/14/2012	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/14/2012	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/17/2010	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/23/2007	SUPPL-4	Labeling		Label is not available on this site.
02/15/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077690

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	202725	AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077690	LUPIN
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205823	PRINSTON INC

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202725	AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077690	LUPIN
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205823	PRINSTON INC

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202725	AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	077690	LUPIN
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	205823	PRINSTON INC

TABLET;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	202725	AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	077690	LUPIN
QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	205823	PRINSTON INC