FDA.reportPublic FDA data

Application 077690

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
002QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
003QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo
004QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-393QuinaprilQuinaprilRebel Distributors CorpANDACurrent
21695-394QuinaprilQuinaprilRebel Distributors CorpANDACurrent
50090-5165QuinaprilQuinaprilA-S Medication SolutionsANDACurrent
50090-5165QuinaprilQuinaprilA-S Medication SolutionsANDACurrent
50090-5165QuinaprilQuinaprilA-S Medication SolutionsANDACurrent
50090-5487QuinaprilQuinaprilA-S Medication SolutionsANDACurrent
50090-5487QuinaprilQuinaprilA-S Medication SolutionsANDACurrent
68001-187QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68001-187QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68001-188QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68001-188QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68001-189QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68001-189QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68001-260QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68001-260QuinaprilQuinaprilBluePoint LaboratoriesANDACurrent
68084-899QuinaprilQuinaprilAmerican Health PackagingANDACurrent
68084-899QuinaprilQuinaprilAmerican Health PackagingANDACurrent
68084-899QuinaprilQuinaprilAmerican Health PackagingANDACurrent
68084-899QuinaprilQuinaprilAmerican Health PackagingANDACurrent
68180-554QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-554QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-554QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-554QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-556QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-556QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-556QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-556QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-557QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-557QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-557QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-557QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-558QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-558QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-558QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
68180-558QuinaprilQuinaprilLupin Pharmaceuticals, Inc.ANDACurrent
70934-582QuinaprilQuinaprilDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-635QuinaprilQuinaprilProficient Rx LPANDACurrent
71205-635QuinaprilQuinaprilProficient Rx LPANDACurrent
71335-1441QuinaprilQuinaprilBryant Ranch PrepackANDACurrent
71335-1441QuinaprilQuinaprilBryant Ranch PrepackANDACurrent
71335-1707QuinaprilQuinaprilBryant Ranch PrepackANDACurrent
71335-1707QuinaprilQuinaprilBryant Ranch PrepackANDACurrent
71335-1707QuinaprilQuinaprilBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23882ORIG2006-07-05