Pilocarpine Oral Tablet

Brand(s)
Salagen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eisai Inc. (2009-12-01)
Oldest Current Product
1994-03-22
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\PILOCARPINE
FDAOB
ORAL\TABLET\PILOCARPINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\PILOCARPINE HYDROCHLORIDE
ORAL\TABLET\PILOCARPINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\PILOCARPINE
ORAL\TABLET\PILOCARPINE

product(s) by strength(s)

pilocarpine hydrochloride 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560705SalagenNDAEisai Inc.1994-03-22PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020237fb4810ec-d26f-429d-b87c-5898a7870169

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000540056ANDARoxane Laboratories, Inc2004-12-222016-03-11PILOCARPINE HYDROCHLORIDEORALTABLETANDA07696316b10412-0031-4e7b-b510-99ae89b138e5
2001155922ANDAGlobal Pharmaceuticals2007-05-01PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0772483a0de319-5390-426c-9c71-76acc03735c7
3002282801NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-09-13PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020237610022b7-7dc9-405a-a580-104657f43bdf
4005271313ANDALannett Company, Inc.2006-01-31PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0772208db0db4f-55ad-46b2-af50-e71b4a763aaa
5101350589ANDAMarlex Pharmaceuticals Inc2014-10-01PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0772200bb77eb0-f518-41bc-8212-8bcd0e75510c
6647200137ANDACorepharma, Llc2004-11-16PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0767462527f4de-4bab-4c25-a624-3884ecd906bf

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790153ANDAKaiser Foundations Hospitals2014-05-29PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATED005271313ANDA0772203353a73f-c619-490a-9f22-9156803c6137
2216950601ANDARebel Distributors Corp2006-03-31PILOCARPINE HYDROCHLORIDEORALTABLET001155922ANDA077248f168b0a9-4e9a-47f7-b391-edcea871956e
3548685436ANDAPhysicians Total Care, Inc.2011-07-21PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATED005271313ANDA077220ecd2428e-b471-4dba-9b22-a81af4065d5a
4680840928NDA AUTHORIZED GENERICAmerican Health Packaging2015-09-01PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATED002282801NDA0202376f950741-fd3f-4bf7-83b0-f5aa9dbceb76

pilocarpine hydrochloride 7.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001155911ANDAGlobal Pharmaceuticals2007-05-01PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0772483a0de319-5390-426c-9c71-76acc03735c7
2002282837NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-09-13PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020237610022b7-7dc9-405a-a580-104657f43bdf
3005271407ANDALannett Company, Inc.2009-08-10PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0772208db0db4f-55ad-46b2-af50-e71b4a763aaa
4101350590ANDAMarlex Pharmaceuticals Inc2014-10-01PILOCARPINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0772200bb77eb0-f518-41bc-8212-8bcd0e75510c

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076746PILOCARPINE HYDROCHLORIDEELAN PHARMA INTERNATIONAL LTD2004-11-16ANDA076746_001
2ANDA076963PILOCARPINE HYDROCHLORIDEROXANE LABORATORIES INC2004-12-22ANDA076963_001, ANDA076963_002
3ANDA077220PILOCARPINE HYDROCHLORIDELANNETT HOLDINGS INC2005-10-14ANDA077220_001, ANDA077220_002
4ANDA077248PILOCARPINE HYDROCHLORIDEIMPAX LABORATORIES INC2006-03-31ANDA077248_001, ANDA077248_002
5NDA020237SALAGENEISAI INC1994-03-22NDA020237_001, NDA020237_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076746_001RXPILOCARPINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2004-11-16PILOCARPINE HYDROCHLORIDE
2ANDA076963_001RXPILOCARPINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2004-12-22PILOCARPINE HYDROCHLORIDE
3ANDA076963_002RXPILOCARPINE HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB2007-02-27PILOCARPINE HYDROCHLORIDE
4ANDA077220_001RXPILOCARPINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2005-10-14PILOCARPINE HYDROCHLORIDE
5ANDA077220_002RXPILOCARPINE HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB2009-05-06PILOCARPINE HYDROCHLORIDE
6ANDA077248_001RXPILOCARPINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2006-03-31PILOCARPINE HYDROCHLORIDE
7ANDA077248_002RXPILOCARPINE HYDROCHLORIDE (7.5MG)ORALTABLETFalseAB2006-03-31PILOCARPINE HYDROCHLORIDE
8NDA020237_001RXPILOCARPINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1994-03-22SALAGEN
9NDA020237_002RXPILOCARPINE HYDROCHLORIDE (7.5MG)ORALTABLETTrueAB2003-04-18SALAGEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10bb77eb0-f518-41bc-8212-8bcd0e75510c (view SPL)Pilocarpine Hydrochloride Tablets, USPprescriptionHuman PrescriptionMarlex Pharmaceuticals Inc2015-03-121101350589, 101350590
216b10412-0031-4e7b-b510-99ae89b138e5 (view SPL)Pilocarpine Hydrochloride Tablets USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2014-03-117000540056
32527f4de-4bab-4c25-a624-3884ecd906bf (view SPL)Pilocarpine Hydrochloride Tablets5 mg Rx onlyprescriptionHuman PrescriptionCorepharma, Llc2012-06-263647200137
43353a73f-c619-490a-9f22-9156803c6137 (view SPL)Pilocarpine Hydrochloride TabletsRx OnlyprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-05-301001790153
53a0de319-5390-426c-9c71-76acc03735c7 (view SPL)PILOCARPINE HYDROCHLORIDE TABLETS,5 MG AND 7.5 MGprescriptionHuman PrescriptionGlobal PharmaceuticalsREPACK2012-02-012001155911, 001155922
6610022b7-7dc9-405a-a580-104657f43bdf (view SPL)Pilocarpine Hydrochloride TabletsprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, LABEL, MANUFACTURE, PACK2009-01-305002282801, 002282837
76f950741-fd3f-4bf7-83b0-f5aa9dbceb76 (view SPL)Pilocarpine Hydrochloride TabletsprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-09-282680840928
88db0db4f-55ad-46b2-af50-e71b4a763aaa (view SPL)Pilocarpine Hydrochloride Tablets, USPRx OnlyprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-09-1611005271313, 005271407
9ecd2428e-b471-4dba-9b22-a81af4065d5a (view SPL)Pilocarpine Hydrochloride TabletsRx OnlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-12-021548685436
10f168b0a9-4e9a-47f7-b391-edcea871956e (view SPL)PILOCARPINE HYDROCHLORIDE TABLETS,5 MGprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-101216950601
11fb4810ec-d26f-429d-b87c-5898a7870169 (view SPL)SALAGENTablets(pilocarpine hydrochloride)prescriptionHuman PrescriptionEisai Inc.MANUFACTURE2009-12-011628560705

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