FDA.reportPublic FDA data

Application 075203

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDETABLET;ORAL150MGNoNo
002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDETABLET;ORAL225MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0582Propafenone HClPropafenone hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-0583Propafenone HClPropafenone hydrochlorideActavis Pharma, Inc.ANDACurrent
50090-2975Propafenone HClPropafenone hydrochlorideA-S Medication SolutionsANDACurrent
50090-2975Propafenone HClPropafenone hydrochlorideA-S Medication SolutionsANDACurrent
63739-509Propafenone HClPropafenone hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-509Propafenone HClPropafenone hydrochlorideMcKesson CorporationANDACurrent
63739-510Propafenone HClPropafenone hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-510Propafenone HClPropafenone hydrochlorideMcKesson CorporationANDACurrent
68084-361Propafenone HClPropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-361Propafenone HClPropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-361Propafenone HClPropafenone hydrochlorideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42957ORIG2003-12-23
39465ORIG2003-12-23
30794ORIG2000-10-24