FDA.reportPublic FDA data

Application 076402

Type
ANDA
Sponsor
CASI PHARMS 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
0185-0053Benazepril HydrochlorideBenazepril HydrochlorideEon Labs, Inc.ANDACurrent
0185-0505Benazepril HydrochlorideBenazepril HydrochlorideEon Labs, Inc.ANDACurrent
0185-0820Benazepril HydrochlorideBenazepril HydrochlorideEon Labs, Inc.ANDACurrent
21695-326Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
21695-327Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
21695-612Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
21695-877Benazepril HydrochlorideBenazepril HydrochlorideRebel Distributors Corp.ANDACurrent
60429-158Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-158Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-159Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-159Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-160Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-160Benazepril HydrochlorideBenazepril HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
68788-6361Benazepril HydrochlorideBenazepril HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9946Benazepril HydrochlorideBenazepril HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9947Benazepril HydrochlorideBenazepril HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31118ORIG2004-02-27