Alprazolam Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-11-24)
Oldest Current Product
1993-10-31
License(s)
ANDA
RxNORM
ORAL SOLUTION\ALPRAZOLAM
FDAOB
ORAL\CONCENTRATE\ALPRAZOLAM
SPL Active
ORAL\SOLUTION, CONCENTRATE\ALPRAZOLAM
SPL Moiety
ORAL\SOLUTION, CONCENTRATE\ALPRAZOLAM

product(s) by strength(s)

alprazolam 1 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543068ANDARoxane Laboratories, Inc1993-10-31ALPRAZOLAMORALSOLUTION, CONCENTRATEANDA074312b945ac6f-796e-41ef-85e9-61007e4a4e9a

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074312ALPRAZOLAMROXANE LABORATORIES INC1993-10-31ANDA074312_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074312_001RXALPRAZOLAM (1MG/ML)ORALCONCENTRATETrue1993-10-31ALPRAZOLAM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b945ac6f-796e-41ef-85e9-61007e4a4e9a (view SPL)prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-11-248000543068

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