FDA.reportPublic FDA data

Application 017078

Type
NDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXEDRINEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL5MGYesNo
002DEXEDRINEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL10MGYesNo
003DEXEDRINEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL15MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9927Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9928Dextroamphetamine SulfateDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-9929Dextroamphetamine SulfateDextroamphetamine SulfateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
52054-512DEXEDRINEdextroamphetamine sulfateAmedra Pharmaceuticals LLCNDACurrent
52054-513DEXEDRINEdextroamphetamine sulfateAmedra Pharmaceuticals LLCNDACurrent
52054-514DEXEDRINEdextroamphetamine sulfateAmedra Pharmaceuticals LLCNDACurrent
54505-327Dextroamphetamine SulfateDextroamphetamine SulfateLineage Therapeutics IncNDA AUTHORIZED GENERICCurrent
54505-328Dextroamphetamine SulfateDextroamphetamine SulfateLineage Therapeutics IncNDA AUTHORIZED GENERICCurrent
54505-329Dextroamphetamine SulfateDextroamphetamine SulfateLineage Therapeutics IncNDA AUTHORIZED GENERICCurrent
64896-673DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-673DEXEDRINEdextroamphetamine sulfateImpax Specialty PharmaNDACurrent
64896-673DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-673DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-674DEXEDRINEdextroamphetamine sulfateImpax Specialty PharmaNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateAmneal Pharmaceuticals LLCNDACurrent
64896-675DEXEDRINEdextroamphetamine sulfateImpax Specialty PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83456SUPPL 2025-09-25
83455SUPPL 2025-09-25
83423SUPPL 2025-09-24
75784SUPPL 2023-10-17
75770SUPPL 2023-10-16
70327SUPPL2022-03-01
70326SUPPL2022-03-01
70285SUPPL2022-02-28
57313SUPPL2019-01-22
57225SUPPL2019-01-16
57224SUPPL2019-01-16
56340SUPPL2018-11-08
48506SUPPL2017-05-24
48481SUPPL2017-05-22
46775SUPPL2017-01-10
46716SUPPL2017-01-06
13081SUPPL2015-04-20
10960SUPPL2015-04-20
10959SUPPL2013-12-12
542SUPPL2013-12-10
10958SUPPL2013-06-18
541SUPPL2013-06-13
33224SUPPL2008-06-12
13080SUPPL2008-05-28
44010ORIG2007-05-18
33223SUPPL2007-05-07
540SUPPL2007-05-07
539SUPPL2006-08-14
10957SUPPL2006-08-11