FDA.reportPublic FDA data

Application 020482

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRECOSEACARBOSETABLET;ORAL50MGYesNo
002PRECOSEACARBOSETABLET;ORAL100MGYesNo
004PRECOSEACARBOSETABLET;ORAL25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-908PrecoseAcarboseAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-951AcarboseacarboseAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
47781-340AcarboseacarboseAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
47781-340AcarboseacarboseAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
47781-341AcarboseacarboseAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
47781-341AcarboseacarboseAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
47781-342AcarboseacarboseAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
47781-342AcarboseacarboseAlvogen, Inc.NDA AUTHORIZED GENERICCurrent
50090-4115AcarboseacarboseA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4115AcarboseacarboseA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4116AcarboseacarboseA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50419-861PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-861PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-861PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-862PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-862PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-862PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-863PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-863PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-863PrecoseAcarboseBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57650ORIG2019-02-15
34697SUPPL2015-03-27
2589SUPPL2015-03-11
2588SUPPL2012-03-02
34696SUPPL2012-03-01
34695SUPPL2011-03-28
25024SUPPL2011-03-25
34694SUPPL2008-08-26
2587SUPPL2008-08-25
34693SUPPL2005-08-03
2586SUPPL2005-08-03
25023SUPPL2002-10-29
20676SUPPL1999-08-16
2585SUPPL1999-08-16
41389SUPPL1998-09-29
25022SUPPL1998-09-29
20675SUPPL1998-09-29
2584SUPPL1998-09-29