Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078450
Company: AUROBINDO PHARMA

• Other Important Information from FDA

Products on ANDA 078450

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078450

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2007	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
05/26/2022	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
05/26/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
05/26/2022	SUPPL-21	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/26/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/16/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/26/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/26/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/26/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/26/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/26/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/26/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/28/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/02/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/30/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078450

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078450	AUROBINDO PHARMA
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076374	CHARTWELL RX

TABLET;ORAL; 12.5MG;EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078450	AUROBINDO PHARMA
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	076374	CHARTWELL RX

TABLET;ORAL; 25MG;EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078450	AUROBINDO PHARMA
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	076374	CHARTWELL RX