Pyridostigmine Injectable Solution

Brand(s)
Regonol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2011-12-29)
Oldest Current Product
2005-05-10
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\PYRIDOSTIGMINE
FDAOB
INJECTION\INJECTION\PYRIDOSTIGMINE BROMIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\PYRIDOSTIGMINE BROMIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\PYRIDOSTIGMINE

product(s) by strength(s)

pyridostigmine bromide 5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813040RegonolNDASandoz Inc2005-05-10PYRIDOSTIGMINE BROMIDEINTRAVENOUSINJECTION, SOLUTIONNDA017398208af931-a44e-43bf-a265-8e08534dc55f

application(s)

#idtitleapplicantapproved drug
1NDA009830MESTINONVALEANT PHARMACEUTICALS INTERNATIONALNDA009830_001
2NDA017398REGONOLSANDOZ CANADA INCNDA017398_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapplication
1NDA009830_001RXPYRIDOSTIGMINE BROMIDE (5MG/ML)INJECTIONTrueAPMESTINON
2NDA017398_001RXPYRIDOSTIGMINE BROMIDE (5MG/ML)INJECTIONFalseAPREGONOL

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1208af931-a44e-43bf-a265-8e08534dc55f (view SPL)Regonol(Pyridostigmine Bromide Injection USP)prescriptionHuman PrescriptionSandoz Inc2011-12-2911007813040

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