Pyridostigmine Oral Tablet

Brand(s)
Mestinon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2015-04-06)
Oldest Current Product
1955-04-06
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\PYRIDOSTIGMINE
FDAOB
ORAL\TABLET\PYRIDOSTIGMINE BROMIDE
SPL Active
ORAL\TABLET\PYRIDOSTIGMINE BROMIDE
SPL Moiety
ORAL\TABLET\PYRIDOSTIGMINE

product(s) by strength(s)

pyridostigmine bromide 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001873010MestinonNDAValeant Pharmaceuticals North America Llc1955-04-06PYRIDOSTIGMINE BROMIDEORALTABLETNDA009829a851795e-b7a8-40c3-9922-5e79d3eb4d92

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001153511ANDAGlobal Pharmaceuticals2003-04-24PYRIDOSTIGMINE BROMIDEORALTABLETANDA0405020f56facf-1f0a-4ba5-876d-757b114dfa45
2658410819ANDACadila Healthcare Limited2015-08-07PYRIDOSTIGMINE BROMIDEORALTABLETANDA205650ea4f753f-41a0-4f82-932c-181883d4b6d3
3683820659ANDAZydus Pharmaceuticals (Usa) Inc.2015-08-07PYRIDOSTIGMINE BROMIDEORALTABLETANDA20565044e8c2dd-3931-4508-9fa7-5a660d6dfddb
4686820302NDA AUTHORIZED GENERICOceanside Pharmaceuticals2007-10-30PYRIDOSTIGMINE BROMIDEORALTABLETNDA0098297e51c874-78f9-4f95-997a-4d09272a8890

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790070ANDAKaiser Foundations Hospitals2010-08-02PYRIDOSTIGMINE BROMIDEORALTABLET647200128ANDA0404579448c360-0ce2-42fe-9f0c-50f2159e8483

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490560ANDARemedyrepack Inc.2011-10-04, 2013-04-03PYRIDOSTIGMINE BROMIDEORALTABLET001153511ANDA040502a91f4260-20d1-48c0-a668-85fc359e1c2f, b63b0989-70cc-46a5-a16d-163e41230896
2680840494ANDAAmerican Health Packaging2011-09-30PYRIDOSTIGMINE BROMIDEORALTABLET001153511ANDA04050230cb0b9f-e308-4501-90c2-b17349c048b7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040457PYRIDOSTIGMINE BROMIDETrueCOREPHARMA LLC2002-12-26ANDA040457_001
2ANDA040502PYRIDOSTIGMINE BROMIDEIMPAX LABORATORIES INC2003-04-24ANDA040502_001
3ANDA040512PYRIDOSTIGMINE BROMIDETrueANI PHARMACEUTICALS INC2003-10-08ANDA040512_001, ANDA040512_002
4ANDA089572PYRIDOSTIGMINE BROMIDETrueSOLVAY PHARMACEUTICALS1990-11-27ANDA089572_001
5ANDA205650PYRIDOSTIGMINE BROMIDEZYDUS PHARMACEUTICALS USA INC2015-06-22ANDA205650_001
6NDA009829MESTINONVALEANT PHARMACEUTICALS NORTH AMERICA LLCNDA009829_002
7NDA020414PYRIDOSTIGMINE BROMIDETrueUNITED STATES ARMY OFFICE SURGEON GENERAL2003-02-05NDA020414_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040457_001discontinuedPYRIDOSTIGMINE BROMIDE (60MG)ORALTABLETFalse2002-12-26PYRIDOSTIGMINE BROMIDE
2ANDA040502_001RXPYRIDOSTIGMINE BROMIDE (60MG)ORALTABLETFalseAB2003-04-24PYRIDOSTIGMINE BROMIDE
3ANDA040512_001discontinuedPYRIDOSTIGMINE BROMIDE (60MG)ORALTABLETFalse2003-10-08PYRIDOSTIGMINE BROMIDE
4ANDA040512_002discontinuedPYRIDOSTIGMINE BROMIDE (30MG)ORALTABLETFalse2005-07-20PYRIDOSTIGMINE BROMIDE
5ANDA089572_001discontinuedPYRIDOSTIGMINE BROMIDE (30MG)ORALTABLETFalse1990-11-27PYRIDOSTIGMINE BROMIDE
6ANDA205650_001RXPYRIDOSTIGMINE BROMIDE (60MG)ORALTABLETFalseAB2015-06-22PYRIDOSTIGMINE BROMIDE
7NDA009829_002RXPYRIDOSTIGMINE BROMIDE (60MG)ORALTABLETTrueABMESTINON
8NDA020414_001discontinuedPYRIDOSTIGMINE BROMIDE (30MG)ORALTABLETFalse2003-02-05PYRIDOSTIGMINE BROMIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10f56facf-1f0a-4ba5-876d-757b114dfa45 (view SPL)PYRIDOSTIGMINE BROMIDE TABLETS USP 60 mgprescriptionHuman PrescriptionGlobal Pharmaceuticals2014-06-094001153511
230cb0b9f-e308-4501-90c2-b17349c048b7 (view SPL)PYRIDOSTIGMINE BROMIDE TABLETS USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-02-062680840494
344e8c2dd-3931-4508-9fa7-5a660d6dfddb (view SPL)Pyridostigmine Bromide Tablets, USP Rx onlyprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.2015-07-011683820659
47e51c874-78f9-4f95-997a-4d09272a8890 (view SPL)PYRIDOSTIGMINE BROMIDE TABLETS USP 60 mgprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-01-134686820302
59448c360-0ce2-42fe-9f0c-50f2159e8483 (view SPL)Pyridostigmine Bromide Tablets, USP60 mgRx onlyprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-08-171001790070
6a851795e-b7a8-40c3-9922-5e79d3eb4d92 (view SPL)MESTINON (pyridostigmine bromide)SYRUPTABLETSandTIMESPANTABLETSprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-04-0610001873010, 001873012, 001873013Pyridostigmine Oral Solution
Pyridostigmine Extended Release Oral Tablet
7a91f4260-20d1-48c0-a668-85fc359e1c2f (view SPL)PYRIDOSTIGMINE BROMIDE TABLETS USP 60 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-031493490560
8b63b0989-70cc-46a5-a16d-163e41230896 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-041493490560
9ea4f753f-41a0-4f82-932c-181883d4b6d3 (view SPL)Pyridostigmine Bromide Tablets, USP Rx onlyprescriptionHuman PrescriptionCadila Healthcare Limited2015-07-011658410819

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