FDA.reportPublic FDA data

Application 201356

Type
ANDA
Sponsor
INVAGEN PHARMS

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
31722-374Quinapril Hydrochloride and HydrochlorothiazideQuinapril Hydrochloride and HydrochlorothiazideCamber PharmaceuticalsANDACurrent
31722-375Quinapril Hydrochloride and HydrochlorothiazideQuinapril Hydrochloride and HydrochlorothiazideCamber PharmaceuticalsANDACurrent
31722-376Quinapril Hydrochloride and HydrochlorothiazideQuinapril Hydrochloride and HydrochlorothiazideCamber PharmaceuticalsANDACurrent
69097-828Quinapril and Hydrochlorothiazide 10/12.5quinapril and Hydrochlorothiazide 10/12.5Cipla USA Inc.ANDACurrent
69097-828Quinapril and Hydrochlorothiazide 10/12.5quinapril and Hydrochlorothiazide 10/12.5Cipla USA Inc.ANDACurrent
69097-828Quinapril and Hydrochlorothiazide 10/12.5quinapril and Hydrochlorothiazide 10/12.5Cipla USA Inc.ANDACurrent
69097-829Quinapril and Hydrochlorothiazide 20/12.5Quinapril and Hydrochlorothiazide 20/12.5Cipla USA Inc.ANDACurrent
69097-829Quinapril and Hydrochlorothiazide 20/12.5Quinapril and Hydrochlorothiazide 20/12.5Cipla USA Inc.ANDACurrent
69097-829Quinapril and Hydrochlorothiazide 20/12.5Quinapril and Hydrochlorothiazide 20/12.5Cipla USA Inc.ANDACurrent
69097-831Quinapril and Hydrochlorothiazide 20/25Quinapril and Hydrochlorothiazide 20/25Cipla USA Inc.ANDACurrent
69097-831Quinapril and Hydrochlorothiazide 20/25Quinapril and Hydrochlorothiazide 20/25Cipla USA Inc.ANDACurrent
69097-831Quinapril and Hydrochlorothiazide 20/25Quinapril and Hydrochlorothiazide 20/25Cipla USA Inc.ANDACurrent