Dextroamphetamine Oral Tablet

Brand(s)
Dexedrine, Zenzedi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Barr Laboratories Inc. (2015-09-28)
Oldest Current Product
2001-02-12
License(s)
ANDA
RxNORM
ORAL TABLET\DEXTROAMPHETAMINE
FDAOB
ORAL\TABLET\DEXTROAMPHETAMINE SULFATE
SPL Active
ORAL\TABLET\DEXTROAMPHETAMINE SULFATE
SPL Moiety
ORAL\TABLET\DEXTROAMPHETAMINE

product(s) by strength(s)

dextroamphetamine sulfate 10 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068959ANDAMallinckrodt, Inc.2010-02-05DEXTROAMPHETAMINE SULFATEORALTABLETANDA040436e05cf690-d45a-4696-a1bf-40c9350cc084
2005550953ANDABarr Laboratories Inc.2001-02-12DEXTROAMPHETAMINE SULFATEORALTABLETANDA040361ec2d13f3-d14f-47e4-abe9-7763f95a8e94
3131070036ANDAAurolife Pharma Llc2012-02-14DEXTROAMPHETAMINE SULFATEORALTABLETANDA20289324163442-dd03-4066-a6ed-eb7e292b700b
4243380853ZenzediANDAArbor Pharmaceuticals, Inc.2013-05-31DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
5466720839ANDAMikart, Inc.2011-10-25DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533a41701b4-2297-400b-84a3-6b868daf1dac
6520540216DexedrineANDAAmedra Pharmaceuticals Llc2014-07-01DEXTROAMPHETAMINE SULFATEORALTABLETANDA0906529ee6fd99-88ea-4cea-8370-a8945581325f
7525360510ANDAWilshire Pharmaceuticals, Inc.2012-07-20DEXTROAMPHETAMINE SULFATEORALTABLETANDA0905336b8c97ac-c83c-4a1f-a33c-121239253abf
8647200216ANDACorepharma, Llc2014-05-15DEXTROAMPHETAMINE SULFATEORALTABLETANDA090652a154799a-5b54-4a5e-b5c3-5c9334a3569e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581770312ANDAEthex Corporation2009-11-01DEXTROAMPHETAMINE SULFATEORALTABLETANDA040367b2ad8d2b-ed94-43cd-95ea-85e91d997f26

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1606870137ANDAAmerican Health Packaging2015-03-31DEXTROAMPHETAMINE SULFATEORALTABLET005550953ANDA040361eedcbd98-e278-4c96-a38b-6147529859de

dextroamphetamine sulfate 15 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380854ZenzediANDAArbor Pharmaceuticals, Inc.2014-05-01DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
2466720840ANDAMikart, Inc.2011-10-25DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533a41701b4-2297-400b-84a3-6b868daf1dac

dextroamphetamine sulfate 2.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380850ZenzediANDAArbor Pharmaceuticals, Inc.2013-05-31DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
2466720836ANDAMikart, Inc.2011-10-25DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533a41701b4-2297-400b-84a3-6b868daf1dac

dextroamphetamine sulfate 20 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380855ZenzediANDAArbor Pharmaceuticals, Inc.2014-05-01DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
2466720841ANDAMikart, Inc.2011-10-25DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533a41701b4-2297-400b-84a3-6b868daf1dac

dextroamphetamine sulfate 30 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380856ZenzediANDAArbor Pharmaceuticals, Inc.2014-05-01DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
2466720842ANDAMikart, Inc.2011-10-25DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533a41701b4-2297-400b-84a3-6b868daf1dac

dextroamphetamine sulfate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068958ANDAMallinckrodt, Inc.2010-02-05DEXTROAMPHETAMINE SULFATEORALTABLETANDA040436e05cf690-d45a-4696-a1bf-40c9350cc084
2005550952ANDABarr Laboratories Inc.2001-02-12DEXTROAMPHETAMINE SULFATEORALTABLETANDA040361ec2d13f3-d14f-47e4-abe9-7763f95a8e94
3131070035ANDAAurolife Pharma Llc2012-02-14DEXTROAMPHETAMINE SULFATEORALTABLETANDA20289324163442-dd03-4066-a6ed-eb7e292b700b
4243380851ZenzediANDAArbor Pharmaceuticals, Inc.2013-05-31DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
5466720837ANDAMikart, Inc.2011-10-25DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533a41701b4-2297-400b-84a3-6b868daf1dac
6520540215DexedrineANDAAmedra Pharmaceuticals Llc2014-07-01DEXTROAMPHETAMINE SULFATEORALTABLETANDA0906529ee6fd99-88ea-4cea-8370-a8945581325f
7525360500ANDAWilshire Pharmaceuticals, Inc.2012-07-16DEXTROAMPHETAMINE SULFATEORALTABLETANDA0905336b8c97ac-c83c-4a1f-a33c-121239253abf
8647200215ANDACorepharma, Llc2014-05-15DEXTROAMPHETAMINE SULFATEORALTABLETANDA090652a154799a-5b54-4a5e-b5c3-5c9334a3569e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581770311ANDAEthex Corporation2009-11-01DEXTROAMPHETAMINE SULFATEORALTABLETANDA040365b2ad8d2b-ed94-43cd-95ea-85e91d997f26

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560387ANDALake Erie Medical Dba Quality Care Products Llc2011-12-07DEXTROAMPHETAMINE SULFATEORALTABLET005550952ANDA040361967951a7-cb68-45b5-b94d-1aad5b0cd025

dextroamphetamine sulfate 7.5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380852ZenzediANDAArbor Pharmaceuticals, Inc.2013-05-31DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
2466720838ANDAMikart, Inc.2011-10-25DEXTROAMPHETAMINE SULFATEORALTABLETANDA090533a41701b4-2297-400b-84a3-6b868daf1dac

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040299DEXTROAMPHETAMINE SULFATETrueVINTAGE PHARMACEUTICALS LLC1999-05-13ANDA040299_001
2ANDA040361DEXTROAMPHETAMINE SULFATEBARR LABORATORIES INC2001-01-31ANDA040361_001, ANDA040361_002
3ANDA040365DEXTROAMPHETAMINE SULFATETrueNESHER PHARMACEUTICALS USA LLC2002-10-31ANDA040365_001
4ANDA040367DEXTROAMPHETAMINE SULFATETrueNESHER PHARMACEUTICALS USA LLC2002-10-31ANDA040367_001
5ANDA040436DEXTROAMPHETAMINE SULFATEMALLINCKRODT INC2002-01-29ANDA040436_001, ANDA040436_002
6ANDA083735DEXAMPEXTrueTEVA PHARMACEUTICALS USA INCANDA083735_001, ANDA083735_002
7ANDA083903DEXTROAMPHETAMINE SULFATETrueLANNETT CO INCANDA083903_001, ANDA083903_003
8ANDA083930DEXTROAMPHETAMINE SULFATETrueHALSEY DRUG CO INCANDA083930_001
9ANDA084001FERNDEXTrueFERNDALE LABORATORIES INCANDA084001_001
10ANDA084051DEXTROSTATTrueSHIRE DEVELOPMENT INCANDA084051_001, ANDA084051_002
11ANDA084125DEXTROAMPHETAMINE SULFATETruePUREPAC PHARMACEUTICAL COANDA084125_001
12ANDA084935DEXEDRINETrueGLAXOSMITHKLINEANDA084935_001
13ANDA084986DEXTROAMPHETAMINE SULFATETrueVITARINE PHARMACEUTICALS INCANDA084986_001
14ANDA085370DEXTROAMPHETAMINE SULFATETrueSANDOZ INCANDA085370_001
15ANDA085371DEXTROAMPHETAMINE SULFATETrueSANDOZ INCANDA085371_001
16ANDA085652DEXTROAMPHETAMINE SULFATETrueLANNETT CO INCANDA085652_001
17ANDA085892DEXTROAMPHETAMINE SULFATETrueVITARINE PHARMACEUTICALS INCANDA085892_001
18ANDA086521DEXTROAMPHETAMINE SULFATETrueMM MAST AND COANDA086521_001
19ANDA090533DEXTROAMPHETAMINE SULFATEMIKART INC2011-10-25ANDA090533_001, ANDA090533_002, ANDA090533_003, ANDA090533_004, ANDA090533_005, ANDA090533_006, ANDA090533_007
20ANDA090652DEXTROAMPHETAMINE SULFATECOREPHARMA LLC2014-03-07ANDA090652_001, ANDA090652_002
21ANDA202893DEXTROAMPHETAMINE SULFATEAUROLIFE PHARMA LLC2013-07-31ANDA202893_001, ANDA202893_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040299_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalse1999-05-13DEXTROAMPHETAMINE SULFATE
2ANDA040361_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAA2001-01-31DEXTROAMPHETAMINE SULFATE
3ANDA040361_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETTrueAA2001-01-31DEXTROAMPHETAMINE SULFATE
4ANDA040365_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalse2002-10-31DEXTROAMPHETAMINE SULFATE
5ANDA040367_001discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalse2002-10-31DEXTROAMPHETAMINE SULFATE
6ANDA040436_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAA2002-01-29DEXTROAMPHETAMINE SULFATE
7ANDA040436_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseAA2002-01-29DEXTROAMPHETAMINE SULFATE
8ANDA083735_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXAMPEX
9ANDA083735_002discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseDEXAMPEX
10ANDA083903_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
11ANDA083903_003discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
12ANDA083930_001discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
13ANDA084001_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseFERNDEX
14ANDA084051_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXTROSTAT
15ANDA084051_002discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseDEXTROSTAT
16ANDA084125_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
17ANDA084935_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXEDRINE
18ANDA084986_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
19ANDA085370_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
20ANDA085371_001discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
21ANDA085652_001discontinuedDEXTROAMPHETAMINE SULFATE (15MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
22ANDA085892_001discontinuedDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
23ANDA086521_001discontinuedDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseDEXTROAMPHETAMINE SULFATE
24ANDA090533_001RXDEXTROAMPHETAMINE SULFATE (2.5MG)ORALTABLETFalse2011-10-25DEXTROAMPHETAMINE SULFATE
25ANDA090533_002RXDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAA2011-10-25DEXTROAMPHETAMINE SULFATE
26ANDA090533_003RXDEXTROAMPHETAMINE SULFATE (7.5MG)ORALTABLETFalse2011-10-25DEXTROAMPHETAMINE SULFATE
27ANDA090533_004RXDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseAA2011-10-25DEXTROAMPHETAMINE SULFATE
28ANDA090533_005RXDEXTROAMPHETAMINE SULFATE (15MG)ORALTABLETFalse2011-10-25DEXTROAMPHETAMINE SULFATE
29ANDA090533_006RXDEXTROAMPHETAMINE SULFATE (20MG)ORALTABLETFalse2011-10-25DEXTROAMPHETAMINE SULFATE
30ANDA090533_007RXDEXTROAMPHETAMINE SULFATE (30MG)ORALTABLETFalse2011-10-25DEXTROAMPHETAMINE SULFATE
31ANDA090652_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAA2014-03-07DEXTROAMPHETAMINE SULFATE
32ANDA090652_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseAA2014-03-07DEXTROAMPHETAMINE SULFATE
33ANDA202893_001RXDEXTROAMPHETAMINE SULFATE (5MG)ORALTABLETFalseAA2013-07-31DEXTROAMPHETAMINE SULFATE
34ANDA202893_002RXDEXTROAMPHETAMINE SULFATE (10MG)ORALTABLETFalseAA2013-07-31DEXTROAMPHETAMINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
124163442-dd03-4066-a6ed-eb7e292b700b (view SPL)Dextroamphetamine Sulfate Tablets, USP CII Rx OnlyprescriptionHuman PrescriptionAurolife Pharma LlcLABEL, MANUFACTURE, PACK, RELABEL, REPACK2015-02-252131070035, 131070036
26b8c97ac-c83c-4a1f-a33c-121239253abf (view SPL)Dextroamphetamine Sulfate Tablets, USP CIIprescriptionHuman PrescriptionWilshire Pharmaceuticals, Inc.2015-04-303525360500, 525360510
3967951a7-cb68-45b5-b94d-1aad5b0cd025 (view SPL)DEXTROAMPHETAMINE SULFATE TABLETS, USP, CIIprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-12-073338353560387
49ee6fd99-88ea-4cea-8370-a8945581325f (view SPL)DEXEDRINE (dextroamphetamine sulfate, USP) TABLETS 5 mg and 10 mg CII Rx onlyprescriptionHuman PrescriptionAmedra Pharmaceuticals Llc2015-03-022520540215, 520540216
5a154799a-5b54-4a5e-b5c3-5c9334a3569e (view SPL)DEXTROAMPHETAMINE SULFATE TABLETS, USP5 mg and 10 mg CIIRx onlyprescriptionHuman PrescriptionCorepharma, Llc2015-02-198647200215, 647200216
6a41701b4-2297-400b-84a3-6b868daf1dac (view SPL)prescriptionHuman PrescriptionMikart, Inc.2015-03-012466720836, 466720837, 466720838, 466720839, 466720840, 466720841, 466720842
7b2ad8d2b-ed94-43cd-95ea-85e91d997f26 (view SPL)Dextroamphetamine Sulfate Tablets, USP, 5 mg and 10 mgprescriptionHuman PrescriptionEthex CorporationANALYSIS, MANUFACTURE2007-04-071581770311, 581770312
8d6394df5-f2c9-47eb-b57e-f3e9cfd94f84 (view SPL)Zenzedi (dextroamphetamine sulfate, USP) CIIprescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2015-05-014243380850, 243380851, 243380852, 243380853, 243380854, 243380855, 243380856
9e05cf690-d45a-4696-a1bf-40c9350cc084 (view SPL)DEXTROAMPHETAMINE SULFATE TABLETS USP 5 mg and 10 mg Rx only CIIprescriptionHuman PrescriptionMallinckrodt, Inc.2015-02-0211004068958, 004068959
10ec2d13f3-d14f-47e4-abe9-7763f95a8e94 (view SPL)DEXTROAMPHETAMINE SULFATE TABLETS USP, CIIprescriptionHuman PrescriptionBarr Laboratories Inc.2015-09-289005550952, 005550953
11eedcbd98-e278-4c96-a38b-6147529859de (view SPL)DEXTROAMPHETAMINE SULFATE TABLETS USP CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-271606870137

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