FDA.reportPublic FDA data

Application 020126

Type
NDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZONALONDOXEPIN HYDROCHLORIDECREAM;TOPICAL5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8117Doxepin HydrochlorideDoxepin HydrochlorideMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8123Zonalondoxepin hydrochlorideMylan Pharmaceuticals Inc.NDACurrent
0378-8130PRUDOXINdoxepin hydrochlorideMylan Pharmaceuticals Inc.NDACurrent
40076-511PRUDOXINdoxepin hydrochloridePrestium Pharma, Inc.NDACurrent
40076-715Zonalondoxepin hydrochloridePrestium Pharma, Inc.NDACurrent
40085-716Doxepin HydrochlorideDoxepin HydrochlorideRenaissance Pharma, Inc.NDA AUTHORIZED GENERICCurrent
70518-0865Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0865Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58714SUPPL2019-05-15
58711SUPPL2019-05-15
57397SUPPL2019-02-01
2049SUPPL2004-07-01
12238SUPPL2003-04-04