FDA.reportPublic FDA data

Application 076118

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL5MGNoNo
002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL10MGNoNo
003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL20MGNoNo
004BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDETABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-561Benazepril HydrochlorideBenazepril HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
13811-627benazepril hydrochlorideBenazepril hydrochlorideTrigen Laboratories, Inc.ANDACurrent
13811-628BENAZEPRIL HYDROCHLORIDEBenazepril hydrochlorideTrigen Laboratories, Inc.ANDACurrent
13811-629BENAZEPRIL HYDROCHLORIDEBenazepril hydrochlorideTrigen Laboratories, Inc.ANDACurrent
13811-630BENAZEPRIL HYDROCHLORIDEBenazepril hydrochlorideTrigen Laboratories, Inc.ANDACurrent
43063-403Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-677Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-677Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-677Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-677Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-677Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-677Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-677Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-679Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-679Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-679Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-679Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-679Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-679Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-679Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-787Benazepril HydrochlorideBenazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43547-335Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-335Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-335Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-335Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-336Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-336Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-336Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-336Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-337Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-337Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-337Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-337Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-338Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-338Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-338Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-338Benazepril HydrochlorideBenazepril HydrochlorideSolco healthcare U.S., LLCANDACurrent
45865-747Benazepril HydrochlorideBenazepril HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-0914Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-3243Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-3243Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-3243Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-3243Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-3775Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-3775Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50090-3775Benazepril HydrochlorideBenazepril HydrochlorideA-S Medication SolutionsANDACurrent
50436-0337Benazepril HydrochlorideBenazepril HydrochlorideUnit Dose ServicesANDACurrent
51407-462Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-462Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-463Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-463Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-464Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-464Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-465Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-465Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51655-065Benazepril HClBenazepril HClNorthwind PharmaceuticalsANDACurrent
51655-066BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
51655-067Benazepril hydrochlorideBenazepril hydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-1233Benazepril HydrochlorideBenazepril HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1248Benazepril HydrochlorideBenazepril HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-190Benazepril HydrochlorideBenazepril HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
54458-862Benazepril HydrochlorideBenazepril HydrochlorideInternational Laboratories, LLCANDACurrent
54458-862Benazepril HydrochlorideBenazepril HydrochlorideInternational Laboratories, LLCANDACurrent
54458-863Benazepril HydrochlorideBenazepril HydrochlorideInternational Laboratories, LLCANDACurrent
54458-863Benazepril HydrochlorideBenazepril HydrochlorideInternational Laboratories, LLCANDACurrent
55700-290Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-290Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-291Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-291Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-291Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-291Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-317Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-317Benazepril HydrochlorideBenazepril HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-351Benazepril HydrochlorideBenazepril HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-352Benazepril HydrochlorideBenazepril HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-739BenazeprilBenazeprilDirect_RxANDACurrent
61919-739BenazeprilBenazeprilDirect_RxANDACurrent
61919-756BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDEDirect_RxANDACurrent
63187-393Benazepril HydrochlorideBenazepril HydrochlorideProficient Rx LPANDACurrent
63187-393Benazepril HydrochlorideBenazepril HydrochlorideProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31078ORIG2004-02-12