FDA.reportPublic FDA data

Application 078540

Type
ANDA
Sponsor
PAR PHARM

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
21695-814Propafenonepropafenone hydrochlorideRebel Distributors CorpANDACurrent
42291-545Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-545Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-545Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-546Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-546Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-546Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-547Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-547Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
42291-547Propafenone Hydrochloridepropafenone hydrochlorideAvKARE, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-113Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-210Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-211Propafenone Hydrochloridepropafenone hydrochloridePar Pharmaceutical, Inc.ANDACurrent
60429-437Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-437Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-437Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-438Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-438Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-438Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-976Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-976Propafenone Hydrochloridepropafenone hydrochlorideGolden State Medical SupplyANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-185Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-674Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
60687-685Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
63629-2269Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2269Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2269Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2270Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2270Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2271Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2271Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2272Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2272Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2273Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2273Propafenone Hydrochloridepropafenone hydrochlorideBryant Ranch PrepackANDACurrent
64380-184Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-184Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-184Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-185Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-185Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-185Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-186Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-186Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
64380-186Propafenone Hydrochloridepropafenone hydrochlorideStrides Pharma Science LimitedANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent
68084-917Propafenone Hydrochloridepropafenone hydrochlorideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22623ORIG2013-10-23
9163ORIG2010-10-20