FDA.reportPublic FDA data

Application 077873

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12.5MG BASENoNo
002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 25MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22615ORIG2013-01-28
44365ORIG2007-07-05
31295ORIG2007-07-05