FDA.reportPublic FDA data

Application 202688

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL225MGNoNo
002PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL325MGNoNo
003PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL425MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2285Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2285Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2285Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2285Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2286Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2286Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2286Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2286Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2287Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2287Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2287Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2287Propafenone HydrochloridePropafenone HydrochlorideActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19367ORIG2015-10-15
10094ORIG2015-08-28