Aspirin Extended Release Oral Capsule

Brand(s)
Durlaza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
New Haven Pharmaceuticals, Inc. (2015-09-25)
Oldest Current Product
2015-09-25
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\ASPIRIN
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\ASPIRIN
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\ASPIRIN
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\ASPIRIN

product(s) by strength(s)

24 hr aspirin 162.5 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584870001DurlazaNDANew Haven Pharmaceuticals, Inc.2015-09-25ASPIRINORALCAPSULE, EXTENDED RELEASENDA2006714c2a1403-3862-1efd-0a91-444989222b37

application(s)

#idtitleapplicantapprovedapproved drug
1NDA200671DURLAZANEW HAVEN PHARMACEUTICALS INC2015-09-04NDA200671_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200671_001RXASPIRIN (162.5MG)ORALCAPSULE, EXTENDED RELEASETrue2015-09-04DURLAZA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14c2a1403-3862-1efd-0a91-444989222b37 (view SPL)These highlights do not include all the information needed to use DURLAZA safely and effectively. See full prescribing information for DURLAZA. DURLAZA (aspirin) Extended Release Capsules, for oral useInitial U.S. Approval:2015prescriptionHuman PrescriptionNew Haven Pharmaceuticals, Inc.MANUFACTURE2015-09-256584870001

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