FDA.reportPublic FDA data

Application 212895

Type
NDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CONJUPRILEVAMLODIPINE MALEATETABLET;ORALEQ 1.25MG BASEYesNo
002CONJUPRILEVAMLODIPINE MALEATETABLET;ORALEQ 2.5MG BASEYesNo
003CONJUPRILEVAMLODIPINE MALEATETABLET;ORALEQ 5MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24075-0410ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
24075-0410ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
24075-0411ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
24075-0411ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
24075-0411ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
24075-0412ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
24075-0412ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
24075-0413ConjuprilevamlodipineCSPC Ouyi Pharmaceutical Co. LtdNDACurrent
42195-425LevamlodipinelevamlodipineXspire Pharma, LLCNDA AUTHORIZED GENERICCurrent
42195-450LevamlodipinelevamlodipineXspire Pharma, LLCNDA AUTHORIZED GENERICCurrent
66992-425ConjuprilevamlodipineWraSer LLCNDACurrent
66992-425ConjuprilevamlodipineWraSer LLCNDACurrent
66992-430ConjuprilevamlodipineWraSer LLCNDACurrent
69101-512Conjuprilevamlodipine maleateBurke Therapeutics, LLCNDACurrent
69101-512ConjuprilevamlodipineBurke Therapeutics, LLCNDACurrent
69101-512ConjuprilevamlodipineBurke Therapeutics, LLCNDACurrent
69101-525Conjuprilevamlodipine maleateBurke Therapeutics, LLCNDACurrent
69101-525ConjuprilevamlodipineBurke Therapeutics, LLCNDACurrent
69101-525ConjuprilevamlodipineBurke Therapeutics, LLCNDACurrent
69101-550Conjuprilevamlodipine maleateBurke Therapeutics, LLCNDACurrent
69101-550ConjuprilevamlodipineBurke Therapeutics, LLCNDACurrent
69101-550ConjuprilevamlodipineBurke Therapeutics, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62687ORIG2020-04-27
61402ORIG2019-12-23
61367ORIG2019-12-20
63117ORIG1900-01-01
63116ORIG1900-01-01