FDA.reportPublic FDA data

Application 078861

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDECONCENTRATE;ORALEQ 20MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-601Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-601Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-601Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-601Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
16714-601Sertraline HydrochlorideSertraline HydrochlorideNorthStar Rx LLCANDACurrent
64980-409Sertraline HydrochlorideSertraline HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-409Sertraline HydrochlorideSertraline HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-409Sertraline HydrochlorideSertraline HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-409Sertraline HydrochlorideSertraline HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
65862-224Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-224Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-224Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-224Sertraline HydrochlorideSertraline HydrochlorideAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44396ORIG2008-11-25