FDA.reportPublic FDA data

Application 078450

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL12.5MG;EQ 10MG BASENoNo
002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL12.5MG;EQ 20MG BASENoNo
003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL25MG;EQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35356-998Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-161Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-161QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-162Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-162Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-162QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-163Quinapril Hydrochloride/HydrochlorothiazideQuinapril Hydrochloride/HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent
65862-163QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEQUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDEAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23907ORIG2007-09-24