Cysteamine Oral Capsule

Brand(s)
Cystagon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2007-07-17)
Oldest Current Product
1994-08-15
License(s)
NDA
RxNORM
ORAL CAPSULE\CYSTEAMINE
FDAOB
ORAL\CAPSULE\CYSTEAMINE BITARTRATE
SPL Active
ORAL\CAPSULE\CYSTEAMINE BITARTRATE
SPL Moiety
ORAL\CAPSULE\CYSTEAMINE

product(s) by strength(s)

cysteamine 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789045CystagonNDAMylan Pharmaceuticals Inc.1994-08-15CYSTEAMINE BITARTRATEORALCAPSULENDA020392f495b76d-96c6-48e5-8fa3-30a4336628eb

cysteamine 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003789040CystagonNDAMylan Pharmaceuticals Inc.1994-08-15CYSTEAMINE BITARTRATEORALCAPSULENDA020392f495b76d-96c6-48e5-8fa3-30a4336628eb

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020392CYSTAGONMYLAN PHARMACEUTICALS INC1994-08-15NDA020392_001, NDA020392_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020392_001RXCYSTEAMINE BITARTRATE (EQ 50MG BASE)ORALCAPSULEFalse1994-08-15CYSTAGON
2NDA020392_002RXCYSTEAMINE BITARTRATE (EQ 150MG BASE)ORALCAPSULETrue1994-08-15CYSTAGON

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1f495b76d-96c6-48e5-8fa3-30a4336628eb (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2007-07-175003789040, 003789045

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