FDA.reportPublic FDA data

Application 077179

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 2.5MG BASE;10MGNoNo
002AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;10MGNoNo
003AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;20MGNoNo
004AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE;20MGNoNo
005AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 5MG BASE;40MGNoNo
006AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7370Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7370Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7370Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7371Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7371Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7371Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7372Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7372Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7372Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7373Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7373Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7373Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7670Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7670Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7670Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7671Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7671Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7671Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
43063-402Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-5366Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7644Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7645Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7645Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7645Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7746Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7746Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
63629-7746Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
68071-1878Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4130Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4130Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
71335-0803Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
71335-0803Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
71335-1383Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent
71335-1383Amlodipine and Benazepril HydrochlorideAmlodipine and Benazepril HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9016ORIG2007-05-29