Dextroamphetamine Extended Release Oral Capsule

Brand(s)
Dexedrine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amedra Pharmaceuticals Llc (2015-02-11)
Oldest Current Product
1976-08-02
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\DEXTROAMPHETAMINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\DEXTROAMPHETAMINE SULFATE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\DEXTROAMPHETAMINE SULFATE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\DEXTROAMPHETAMINE

product(s) by strength(s)

dextroamphetamine sulfate 10 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1520540513DexedrineNDAAmedra Pharmaceuticals Llc1976-08-02DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASENDA017078a37b6ef9-78b4-4b18-8797-ecb583502500

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068961ANDAMallinckrodt, Inc.2011-10-07DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA07635369c40af8-3710-46bf-bd3d-137fe5eea23e
2005550955ANDABarr Laboratories Inc.2002-02-26DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA076137a0860402-057c-40ce-902c-6ec5d6545132
3459630304ANDAActavis Inc.2014-06-19DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2039019e92ccc3-d81c-461d-a19f-7e9b582be357
4545050328NDA AUTHORIZED GENERICLineage Therapeutics Inc1976-08-02DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0170786ca9dd45-08f8-11e3-8ffd-0800200c9a66

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685479ANDAPhysicians Total Care, Inc.2005-11-30DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASE005550955ANDA076137421cf8e0-ef59-4a19-9d1c-e1ec6596f32b
2606870141ANDAAmerican Health Packaging2015-03-31DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASE005550955ANDA0761370fd7019a-eebd-47a7-997d-cb888a9549be

dextroamphetamine sulfate 15 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1520540514DexedrineNDAAmedra Pharmaceuticals Llc1976-08-02DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASENDA017078a37b6ef9-78b4-4b18-8797-ecb583502500

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068962ANDAMallinckrodt, Inc.2011-10-07DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA07635369c40af8-3710-46bf-bd3d-137fe5eea23e
2005550956ANDABarr Laboratories Inc.2002-02-26DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA076137a0860402-057c-40ce-902c-6ec5d6545132
3459630305ANDAActavis Inc.2014-06-19DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2039019e92ccc3-d81c-461d-a19f-7e9b582be357
4545050329NDA AUTHORIZED GENERICLineage Therapeutics Inc1976-08-02DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0170786ca9dd45-08f8-11e3-8ffd-0800200c9a66

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685388ANDAPhysicians Total Care, Inc.2005-08-15DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASE005550956ANDA076137421cf8e0-ef59-4a19-9d1c-e1ec6596f32b
2606870150ANDAAmerican Health Packaging2015-06-01DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASE004068962ANDA076353669a308e-ce09-4ac8-84d9-ee252c5d3223

dextroamphetamine sulfate 5 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1520540512DexedrineNDAAmedra Pharmaceuticals Llc1976-08-02DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASENDA017078a37b6ef9-78b4-4b18-8797-ecb583502500

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068960ANDAMallinckrodt, Inc.2011-10-07DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA07635369c40af8-3710-46bf-bd3d-137fe5eea23e
2005550954ANDABarr Laboratories Inc.2002-02-26DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA076137a0860402-057c-40ce-902c-6ec5d6545132
3459630303ANDAActavis Inc.2014-06-19DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2039019e92ccc3-d81c-461d-a19f-7e9b582be357
4545050327NDA AUTHORIZED GENERICLineage Therapeutics Inc1976-08-02DEXTROAMPHETAMINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0170786ca9dd45-08f8-11e3-8ffd-0800200c9a66

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076137DEXTROAMPHETAMINE SULFATEBARR LABORATORIES INC2002-01-18ANDA076137_001, ANDA076137_002, ANDA076137_003
2ANDA076353DEXTROAMPHETAMINE SULFATEMALLINCKRODT INC2003-05-06ANDA076353_001, ANDA076353_002, ANDA076353_003
3ANDA076814DEXTROAMPHETAMINE SULFATETrueABLE LABORATORIES INC2004-08-25ANDA076814_001, ANDA076814_002, ANDA076814_003
4ANDA203901DEXTROAMPHETAMINE SULFATEACTAVIS ELIZABETH LLC2012-11-30ANDA203901_001, ANDA203901_002, ANDA203901_003
5NDA017078DEXEDRINEAMEDRA PHARMACEUTICALS LLCNDA017078_001, NDA017078_002, NDA017078_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076137_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2002-01-18DEXTROAMPHETAMINE SULFATE
2ANDA076137_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2002-01-18DEXTROAMPHETAMINE SULFATE
3ANDA076137_003RXDEXTROAMPHETAMINE SULFATE (15MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2002-01-18DEXTROAMPHETAMINE SULFATE
4ANDA076353_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2003-05-06DEXTROAMPHETAMINE SULFATE
5ANDA076353_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2003-05-06DEXTROAMPHETAMINE SULFATE
6ANDA076353_003RXDEXTROAMPHETAMINE SULFATE (15MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2003-05-06DEXTROAMPHETAMINE SULFATE
7ANDA076814_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALCAPSULE, EXTENDED RELEASEFalse2004-08-25DEXTROAMPHETAMINE SULFATE
8ANDA076814_002discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALCAPSULE, EXTENDED RELEASEFalse2004-08-25DEXTROAMPHETAMINE SULFATE
9ANDA076814_003discontinuedDEXTROAMPHETAMINE SULFATE (15MG)ORALCAPSULE, EXTENDED RELEASEFalse2004-08-25DEXTROAMPHETAMINE SULFATE
10ANDA203901_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2012-11-30DEXTROAMPHETAMINE SULFATE
11ANDA203901_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2012-11-30DEXTROAMPHETAMINE SULFATE
12ANDA203901_003RXDEXTROAMPHETAMINE SULFATE (15MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2012-11-30DEXTROAMPHETAMINE SULFATE
13NDA017078_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALCAPSULE, EXTENDED RELEASEFalseABDEXEDRINE
14NDA017078_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseABDEXEDRINE
15NDA017078_003RXDEXTROAMPHETAMINE SULFATE (15MG)ORALCAPSULE, EXTENDED RELEASETrueABDEXEDRINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10fd7019a-eebd-47a7-997d-cb888a9549be (view SPL)DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULESCIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-271606870141
2421cf8e0-ef59-4a19-9d1c-e1ec6596f32b (view SPL)DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES - CIIprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-182548685388, 548685479
3669a308e-ce09-4ac8-84d9-ee252c5d3223 (view SPL)DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES CIIprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-11-233606870150
469c40af8-3710-46bf-bd3d-137fe5eea23e (view SPL)DEXTROAMPHETAMINE SULFATEEXTENDED-RELEASE CAPSULES CII Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-02-0211004068960, 004068961, 004068962
56ca9dd45-08f8-11e3-8ffd-0800200c9a66 (view SPL)DEXTROAMPHETAMINE SULFATE EXTENDED RELEASE CAPSULES CII RX ONLYprescriptionHuman PrescriptionLineage Therapeutics Inc2015-02-116545050327, 545050328, 545050329
69e92ccc3-d81c-461d-a19f-7e9b582be357 (view SPL)Dextroamphetamine Sulfate Extended-Release CapsulesprescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-05-195459630303, 459630304, 459630305
7a0860402-057c-40ce-902c-6ec5d6545132 (view SPL)DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES CIIprescriptionHuman PrescriptionBarr Laboratories Inc.2015-05-218005550954, 005550955, 005550956
8a37b6ef9-78b4-4b18-8797-ecb583502500 (view SPL)DEXEDRINE (dextroamphetamine sulfate) SPANSULE sustained release capsules CIIRx OnlyprescriptionHuman PrescriptionAmedra Pharmaceuticals Llc2015-02-1111520540512, 520540513, 520540514

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII