Phenelzine Oral Tablet

Brand(s)
Nardil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2014-10-14)
Oldest Current Product
1961-06-09
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\PHENELZINE
FDAOB
ORAL\TABLET\PHENELZINE SULFATE
SPL Active
ORAL\TABLET, FILM COATED\PHENELZINE SULFATE
ORAL\TABLET\PHENELZINE SULFATE
SPL Moiety
ORAL\TABLET, FILM COATED\PHENELZINE
ORAL\TABLET\PHENELZINE

product(s) by strength(s)

phenelzine 15 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597620119NDAGreenstone Llc1961-06-09PHENELZINE SULFATEORALTABLET, FILM COATEDNDA011909fa041652-fdde-4794-a8d2-279dd309e075

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320360ANDANovel Laboratories, Inc.2011-02-14PHENELZINE SULFATEORALTABLETANDA200181b7ec6ae7-3d76-42aa-9d8a-fc3e187769b5
2433860360ANDAGavis Pharmaceuticals, Llc2010-12-14PHENELZINE SULFATEORALTABLETANDA20018140483372-448f-4284-976c-8462ef256661

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290348ANDAGolden State Medical Supply, Inc.2010-12-14PHENELZINE SULFATEORALTABLET433860360ANDA200181afd48e96-a64e-4e5a-ba21-504a53855397

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA200181PHENELZINE SULFATENOVEL LABORATORIES INC2010-12-08ANDA200181_001
2NDA011909NARDILPARKE DAVIS DIV WARNER LAMBERT CONDA011909_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200181_001RXPHENELZINE SULFATE (EQ 15MG BASE)ORALTABLETFalseAB2010-12-08PHENELZINE SULFATE
2NDA011909_002RXPHENELZINE SULFATE (EQ 15MG BASE)ORALTABLETTrueABNARDIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
140483372-448f-4284-976c-8462ef256661 (view SPL)PHENELZINE SULFATE TABLETS, USPprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2010-12-111433860360
2513a41d0-37d4-4355-8a6d-a2c643bce6fa (view SPL)NARDIL (Phenelzine Sulfate Tablets, USP)prescriptionHuman PrescriptionParke-Davis Div Of Pfizer IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-02-028000710350
3afd48e96-a64e-4e5a-ba21-504a53855397 (view SPL)PHENELZINE SULFATE TABLETS, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290348
4b7ec6ae7-3d76-42aa-9d8a-fc3e187769b5 (view SPL)PHENELZINE SULFATE TABLETS, USP Novel Laboratories, Inc. Rx OnlyprescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2014-09-302400320360
5fa041652-fdde-4794-a8d2-279dd309e075 (view SPL)PHENELZINE SULFATE Tablets, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-10-144597620119

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