Selegiline Oral Capsule

Brand(s)
Eldepryl
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Specialty L.P. (2012-06-26)
Oldest Current Product
1997-07-15
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\SELEGILINE
FDAOB
ORAL\CAPSULE\SELEGILINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\SELEGILINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\SELEGILINE

product(s) by strength(s)

selegiline hydrochloride 5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1495020420EldeprylNDAMylan Specialty L.P.2012-07-02SELEGILINE HYDROCHLORIDEORALCAPSULENDA020647106429ad-859a-4b29-babf-42cb85f7236e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1605050055ANDAApotex Corp1997-07-15SELEGILINE HYDROCHLORIDEORALCAPSULEANDA0753211924db3d-6a16-4496-cfd0-6903be146925
2672530700ANDADava Pharmaceuticals, Inc.2006-11-04SELEGILINE HYDROCHLORIDEORALCAPSULEANDA075352d7bc252a-cfe9-419d-9e89-727563071e5b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1557000076ANDALake Erie Medical Dba Quality Care Products Llc1997-07-15SELEGILINE HYDROCHLORIDEORALCAPSULE605050055ANDA075321ed802863-bf91-46a4-9c44-a6c5ce905edc
2604290019ANDAGolden State Medical Supply, Inc.2006-11-04SELEGILINE HYDROCHLORIDEORALCAPSULE672530700ANDA075352c71c9f45-4b15-49af-ba29-680c66836c9a
3681512649ANDACarilion Materials Management2006-11-04SELEGILINE HYDROCHLORIDEORALCAPSULE672530700ANDA075352dcd786c2-fdf6-46fd-b05f-1618ab6536ab

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075145SELEGILINE HYDROCHLORIDETrueLANNETT HOLDINGS INC2003-09-15ANDA075145_001
2ANDA075321SELEGILINE HYDROCHLORIDEAPOTEX INC1998-12-04ANDA075321_001
3ANDA075352SELEGILINE HYDROCHLORIDEDAVA PHARMACEUTICALS INC1998-11-30ANDA075352_001
4NDA020647ELDEPRYLSOMERSET PHARMACEUTICALS INC1996-05-15NDA020647_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075145_001discontinuedSELEGILINE HYDROCHLORIDE (5MG)ORALCAPSULEFalse2003-09-15SELEGILINE HYDROCHLORIDE
2ANDA075321_001RXSELEGILINE HYDROCHLORIDE (5MG)ORALCAPSULEFalseAB1998-12-04SELEGILINE HYDROCHLORIDE
3ANDA075352_001RXSELEGILINE HYDROCHLORIDE (5MG)ORALCAPSULEFalseAB1998-11-30SELEGILINE HYDROCHLORIDE
4NDA020647_001RXSELEGILINE HYDROCHLORIDE (5MG)ORALCAPSULETrueAB1996-05-15ELDEPRYL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1106429ad-859a-4b29-babf-42cb85f7236e (view SPL)prescriptionHuman PrescriptionMylan Specialty L.P.2012-06-262495020420
21924db3d-6a16-4496-cfd0-6903be146925 (view SPL)Selegiline Hydrochloride Capsules, 5 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-08-203605050055
3c71c9f45-4b15-49af-ba29-680c66836c9a (view SPL)SELEGILINE HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2014-12-312604290019
4d7bc252a-cfe9-419d-9e89-727563071e5b (view SPL)SELEGILINE HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2011-03-072672530700
5dcd786c2-fdf6-46fd-b05f-1618ab6536ab (view SPL)SELEGILINE HYDROCHLORIDE CAPSULESprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2009-10-202681512649
6ed802863-bf91-46a4-9c44-a6c5ce905edc (view SPL)Selegiline Hydrochloride Capsules, 5 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2015-05-071557000076

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