acrivastine / Pseudoephedrine Oral Capsule

Brand(s)
Semprex-D
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actient Pharmaceuticals, Llc (2015-05-05)
Oldest Current Product
2012-01-26
License(s)
NDA
RxNORM
ORAL CAPSULE\ACRIVASTINE:PSEUDOEPHEDRINE
FDAOB
ORAL\CAPSULE\ACRIVASTINE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\ACRIVASTINE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\ACRIVASTINE: PSEUDOEPHEDRINE

product(s) by strength(s)

acrivastine 8 mg / pseudoephedrine hydrochloride 60 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1522440404Semprex-DNDAActient Pharmaceuticals, Llc2012-01-26ACRIVASTINE, PSEUDOEPHEDRINE HYDROCHLORIDEORALCAPSULENDA019806d86c6a13-9e5f-43c2-92f5-c7ed7bfcedfc

application(s)

#idtitleapplicantapprovedapproved drug
1NDA019806SEMPREX-DAUXILIUM PHARMACEUTICALS LLC1994-03-25NDA019806_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA019806_001RXPSEUDOEPHEDRINE HYDROCHLORIDE (60MG), ACRIVASTINE (8MG)ORALCAPSULETrue1994-03-25SEMPREX-D

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1d86c6a13-9e5f-43c2-92f5-c7ed7bfcedfc (view SPL)Semprex-D Capsules(acrivastine and pseudoephedrine hydrochloride)prescriptionHuman PrescriptionActient Pharmaceuticals, Llc2015-05-054522440404

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