Pyridostigmine Extended Release Oral Tablet

Brand(s)
Mestinon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oceanside Pharmaceuticals (2015-08-01)
Oldest Current Product
1959-01-12
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\PYRIDOSTIGMINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\PYRIDOSTIGMINE BROMIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\PYRIDOSTIGMINE BROMIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\PYRIDOSTIGMINE

product(s) by strength(s)

pyridostigmine bromide 180 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1686820301NDAOceanside Pharmaceuticals1959-01-12PYRIDOSTIGMINE BROMIDEORALTABLET, EXTENDED RELEASENDA0116657cf12f6c-4c6c-474b-895a-93151d657ca6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151404ANDAGlobal Pharmaceuticals2015-09-18PYRIDOSTIGMINE BROMIDEORALTABLET, EXTENDED RELEASEANDA203184013a6524-6eb9-4dbf-b29c-9aec2f40d2d0
2477810335ANDAAlvogen, Inc.2015-06-29PYRIDOSTIGMINE BROMIDEORALTABLET, EXTENDED RELEASEANDA20473793454159-0c58-1980-34b9-4038a2260420

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA203184PYRIDOSTIGMINE BROMIDEIMPAX LABORATORIES INC2015-09-15ANDA203184_001
2ANDA204737PYRIDOSTIGMINE BROMIDEALVOGEN INC2015-06-26ANDA204737_001
3NDA011665MESTINONVALEANT PHARMACEUTICALS NORTH AMERICA LLCNDA011665_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203184_001RXPYRIDOSTIGMINE BROMIDE (180MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-09-15PYRIDOSTIGMINE BROMIDE
2ANDA204737_001RXPYRIDOSTIGMINE BROMIDE (180MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-06-26PYRIDOSTIGMINE BROMIDE
3NDA011665_001RXPYRIDOSTIGMINE BROMIDE (180MG)ORALTABLET, EXTENDED RELEASETrueABMESTINON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1013a6524-6eb9-4dbf-b29c-9aec2f40d2d0 (view SPL)PYRIDOSTIGMINE BROMIDE EXTENDED-RELEASE TABLETS, 180 mgprescriptionHuman PrescriptionGlobal Pharmaceuticals2015-09-297001151404
27cf12f6c-4c6c-474b-895a-93151d657ca6 (view SPL)Pyridostigmine bromide extended-release tablets, 180 MGprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-08-011686820301
393454159-0c58-1980-34b9-4038a2260420 (view SPL)Pyridostigmine Bromide Extended release Tablets, 180 mgRx OnlyprescriptionHuman PrescriptionAlvogen, Inc.analysis, manufacture, pack2012-09-254477810335
4a851795e-b7a8-40c3-9922-5e79d3eb4d92 (view SPL)MESTINON (pyridostigmine bromide)SYRUPTABLETSandTIMESPANTABLETSprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-04-0610001873010, 001873012, 001873013Pyridostigmine Oral Solution
Pyridostigmine Oral Tablet

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