Methamphetamine Oral Tablet

Brand(s)
Desoxyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Recordati Rare Diseases, Inc. (2015-02-23)
Oldest Current Product
1943-12-31
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\METHAMPHETAMINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\METHAMPHETAMINE HYDROCHLORIDE
ORAL\TABLET\METHAMPHETAMINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\METHAMPHETAMINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\METHAMPHETAMINE

product(s) by strength(s)

methamphetamine hydrochloride 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1552920102DesoxynNDARecordati Rare Diseases, Inc.1943-12-31METHAMPHETAMINE HYDROCHLORIDEORALTABLETNDA005378f03a68d5-ed00-8a2d-af68-28be909ea85f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003788115ANDAMylan Pharmaceuticals Inc.2010-04-26METHAMPHETAMINE HYDROCHLORIDEORALTABLETANDA09118915e150c7-1347-40fb-9f58-c390521bc6f9
2683080115ANDAMayne Pharma Inc.2010-04-26METHAMPHETAMINE HYDROCHLORIDEORALTABLETANDA091189f31f580f-1f08-4a0f-b078-0b9e3308f712

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040529METHAMPHETAMINE HYDROCHLORIDETrueABLE LABORATORIES INC2004-02-25ANDA040529_001
2ANDA083889METHAMPEXTrueTEVA PHARMACEUTICALS USA INCANDA083889_001
3ANDA084931METHAMPHETAMINE HYDROCHLORIDETrueREXAR PHARMACALANDA084931_001, ANDA084931_002
4ANDA086359METHAMPHETAMINE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INCANDA086359_001
5ANDA091189METHAMPHETAMINE HYDROCHLORIDECOASTAL PHARMACEUTICALS2010-04-21ANDA091189_001
6NDA005378DESOXYNRECORDATI RARE DISEASES INCNDA005378_002, NDA005378_003, NDA005378_004, NDA005378_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040529_001discontinuedMETHAMPHETAMINE HYDROCHLORIDE (5MG)ORALTABLETFalse2004-02-25METHAMPHETAMINE HYDROCHLORIDE
2ANDA083889_001discontinuedMETHAMPHETAMINE HYDROCHLORIDE (10MG)ORALTABLETFalseMETHAMPEX
3ANDA084931_001discontinuedMETHAMPHETAMINE HYDROCHLORIDE (5MG)ORALTABLETFalseMETHAMPHETAMINE HYDROCHLORIDE
4ANDA084931_002discontinuedMETHAMPHETAMINE HYDROCHLORIDE (10MG)ORALTABLETFalseMETHAMPHETAMINE HYDROCHLORIDE
5ANDA086359_001discontinuedMETHAMPHETAMINE HYDROCHLORIDE (5MG)ORALTABLETFalseMETHAMPHETAMINE HYDROCHLORIDE
6ANDA091189_001RXMETHAMPHETAMINE HYDROCHLORIDE (5MG)ORALTABLETFalseAA2010-04-21METHAMPHETAMINE HYDROCHLORIDE
7NDA005378_002RXMETHAMPHETAMINE HYDROCHLORIDE (5MG)ORALTABLETTrueAADESOXYN
8NDA005378_003discontinuedMETHAMPHETAMINE HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseDESOXYN
9NDA005378_004discontinuedMETHAMPHETAMINE HYDROCHLORIDE (5MG)ORALTABLET, EXTENDED RELEASEFalseDESOXYN
10NDA005378_005discontinuedMETHAMPHETAMINE HYDROCHLORIDE (15MG)ORALTABLET, EXTENDED RELEASEFalseDESOXYN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
115e150c7-1347-40fb-9f58-c390521bc6f9 (view SPL)Methamphetamine Hydrochloride Tablets, USPprescriptionHuman PrescriptionMylan Pharmaceuticals Inc.MANUFACTURE2014-01-085003788115
2f03a68d5-ed00-8a2d-af68-28be909ea85f (view SPL)Desoxyn (methamphetamine hydrochloride tablets, USP) CII Rx onlyprescriptionHuman PrescriptionRecordati Rare Diseases, Inc.MANUFACTURE2015-02-234552920102
3f31f580f-1f08-4a0f-b078-0b9e3308f712 (view SPL)Methamphetamine Hydrochloride Tablets, USPprescriptionHuman PrescriptionMayne Pharma Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-05-132683080115

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