Selegiline Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Apotex Corp (2012-07-11)
Oldest Current Product
1997-07-06
License(s)
ANDA
RxNORM
ORAL TABLET\SELEGILINE
FDAOB
ORAL\TABLET\SELEGILINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\SELEGILINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\SELEGILINE

product(s) by strength(s)

selegiline hydrochloride 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789290ANDAMylan Pharmaceuticals Inc.2010-03-08SELEGILINE HYDROCHLORIDEORALTABLETANDA074866438207da-aff2-4e6e-8ef3-13b35295bea4
2518620146ANDALibertas Pharma, Inc.2014-05-24SELEGILINE HYDROCHLORIDEORALTABLETANDA074912ea090c94-1e09-4771-98d7-4f3444650a7d
3605053438ANDAApotex Corp1997-07-06SELEGILINE HYDROCHLORIDEORALTABLETANDA0748712aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290176ANDAGolden State Medical Supply, Inc.2013-04-02SELEGILINE HYDROCHLORIDEORALTABLET605053438ANDA074871040a97e5-efd1-4a2f-b737-2f13e5366d70

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074537SELEGILINE HYDROCHLORIDETrueG AND W LABORATORIES INC1996-08-02ANDA074537_001
2ANDA074565SELEGILINE HYDROCHLORIDETrueVINTAGE PHARMACEUTICALS LLC1996-08-02ANDA074565_001
3ANDA074641SELEGILINE HYDROCHLORIDETrueDAVA PHARMACEUTICALS INC1996-08-02ANDA074641_001
4ANDA074672SELEGILINE HYDROCHLORIDETrueSIEGFRIED LTD1997-04-01ANDA074672_001
5ANDA074744SELEGILINE HYDROCHLORIDETrueG AND W LABORATORIES INC1997-01-27ANDA074744_001
6ANDA074756SELEGILINE HYDROCHLORIDETrueG AND W LABORATORIES INC1998-11-25ANDA074756_001
7ANDA074866SELEGILINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1997-11-26ANDA074866_001
8ANDA074871SELEGILINE HYDROCHLORIDEAPOTEX INC ETOBICOKE SITE1997-06-06ANDA074871_001
9ANDA074912SELEGILINE HYDROCHLORIDESTASON INDUSTRIAL CORP1998-04-30ANDA074912_001
10NDA019334SELEGILINE HYDROCHLORIDETrueSOMERSET PHARMACEUTICALS INC1989-06-05NDA019334_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074537_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalse1996-08-02SELEGILINE HYDROCHLORIDE
2ANDA074565_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalse1996-08-02SELEGILINE HYDROCHLORIDE
3ANDA074641_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalse1996-08-02SELEGILINE HYDROCHLORIDE
4ANDA074672_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalse1997-04-01SELEGILINE HYDROCHLORIDE
5ANDA074744_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalse1997-01-27SELEGILINE HYDROCHLORIDE
6ANDA074756_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalse1998-11-25SELEGILINE HYDROCHLORIDE
7ANDA074866_001RXSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1997-11-26SELEGILINE HYDROCHLORIDE
8ANDA074871_001RXSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETTrueAB1997-06-06SELEGILINE HYDROCHLORIDE
9ANDA074912_001RXSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1998-04-30SELEGILINE HYDROCHLORIDE
10NDA019334_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALTABLETFalse1989-06-05SELEGILINE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1040a97e5-efd1-4a2f-b737-2f13e5366d70 (view SPL)Selegiline Hydrochloride Tablets USP 5 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-12-312604290176
22aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2 (view SPL)Selegiline Hydrochloride Tablets USP 5 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2012-07-112605053438
3438207da-aff2-4e6e-8ef3-13b35295bea4 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2009-11-268003789290
4ea090c94-1e09-4771-98d7-4f3444650a7d (view SPL)SELEGILINE HYDROCHLORIDE TABLETS USP 5 MGprescriptionHuman PrescriptionLibertas Pharma, Inc.2014-05-201518620146

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