FDA.reportPublic FDA data

Application 090011

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 5MG BASE;160MGNoNo
002AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 10MG BASE;160MGNoNo
003AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 5MG BASE;320MGNoNo
004AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 10MG BASE;320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-020Amlodipine and Valsartanamlodipine and valsartanAvKAREANDACurrent
42291-020Amlodipine and Valsartanamlodipine and valsartanAvKARE, Inc.ANDACurrent
42291-022Amlodipine and Valsartanamlodipine and valsartanAvKARE, Inc.ANDACurrent
42291-022Amlodipine and Valsartanamlodipine and valsartanAvKAREANDACurrent
42291-022Amlodipine and Valsartanamlodipine and valsartanAvKAREANDACurrent
42291-023Amlodipine and Valsartanamlodipine and valsartanAvKARE, Inc.ANDACurrent
49884-574Amlodipine and Valsartanamlodipine and valsartanPar Pharmaceutical, Inc.ANDACurrent
49884-574Amlodipine and Valsartanamlodipine and valsartanPar Pharmaceutical, Inc.ANDACurrent
49884-575Amlodipine and Valsartanamlodipine and valsartanPar Pharmaceutical, Inc.ANDACurrent
49884-575Amlodipine and Valsartanamlodipine and valsartanPar Pharmaceutical, Inc.ANDACurrent
49884-577Amlodipine and Valsartanamlodipine and valsartanPar Pharmaceutical, Inc.ANDACurrent
49884-577Amlodipine and Valsartanamlodipine and valsartanPar Pharmaceutical, Inc.ANDACurrent
64380-214Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-214Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-214Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-215Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-215Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-215Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-216Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-216Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-216Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-217Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-217Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent
64380-217Amlodipine and Valsartanamlodipine and valsartanStrides Pharma Science LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31439ORIG2013-04-02