Disopyramide Extended Release Oral Capsule

Brand(s)
Norpace
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
G.D. Searle Llc Division Of Pfizer Inc (2010-02-24)
Oldest Current Product
1982-07-20
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\DISOPYRAMIDE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\DISOPYRAMIDE PHOSPHATE
SPL Active
ORAL\CAPSULE, GELATIN COATED\DISOPYRAMIDE PHOSPHATE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\DISOPYRAMIDE

product(s) by strength(s)

12 hr disopyramide 100 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000252732NorpaceNDAG.D. Searle Llc Division Of Pfizer Inc1982-07-20DISOPYRAMIDE PHOSPHATEORALCAPSULE, GELATIN COATEDNDA018655e2aa1642-d262-4520-bc6a-9fd3ad795677

12 hr disopyramide 150 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000252742NorpaceNDAG.D. Searle Llc Division Of Pfizer Inc1982-07-20DISOPYRAMIDE PHOSPHATEORALCAPSULE, GELATIN COATEDNDA018655e2aa1642-d262-4520-bc6a-9fd3ad795677

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA071200DISOPYRAMIDE PHOSPHATETrueNESHER PHARMACEUTICALS USA LLC1987-12-15ANDA071200_001Disopyramide Oral Capsule
2NDA018655NORPACE CRGD SEARLE LLC1982-07-20NDA018655_001, NDA018655_002Disopyramide Oral Capsule

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071200_001discontinuedDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse1987-12-15DISOPYRAMIDE PHOSPHATE
2NDA018655_001RXDISOPYRAMIDE PHOSPHATE (EQ 100MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse1982-07-20NORPACE CR
3NDA018655_002RXDISOPYRAMIDE PHOSPHATE (EQ 150MG BASE)ORALCAPSULE, EXTENDED RELEASETrueAB1982-07-20NORPACE CR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1e2aa1642-d262-4520-bc6a-9fd3ad795677 (view SPL)Norpace disopyramide phosphate capsules Norpace CRdisopyramide phosphateextended-release capsulesprescriptionHuman PrescriptionG.D. Searle Llc Division Of Pfizer IncAPI MANUFACTURE, MANUFACTURE2010-02-243000252732, 000252742, 000252752, 000252762Disopyramide Oral Capsule

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