Acetaminophen / Oxycodone Oral Solution

Brand(s)
Roxicet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-07-02)
Oldest Current Product
1986-12-03
License(s)
ANDA
RxNORM
ORAL SOLUTION\ACETAMINOPHEN:OXYCODONE
FDAOB
ORAL\SOLUTION\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\ACETAMINOPHEN: OXYCODONE

product(s) by strength(s)

acetaminophen 65 mg/ml / oxycodone hydrochloride 1 mg/ml oral solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000543686RoxicetANDARoxane Laboratories, Inc1986-12-03ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA08935186817b05-450c-4af0-aeea-acba2ac00601
2000548648RoxicetANDARoxane Laboratories, Inc1991-01-172016-07-02ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA08935186817b05-450c-4af0-aeea-acba2ac00601
3006031492ANDAQualitest Pharmaceuticals2014-12-18ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA2035738f0eccce-728f-4039-959b-4887ae32325f

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068553ANDAMallinckrodt, Inc.2011-03-10ACETAMINOPHEN, OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA0406801affabf4-d808-4dc4-ad48-ea4fc9b3c28d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040680OXYCODONE AND ACETAMINOPHENTrueMALLINCKRODT INC2006-09-29ANDA040680_001
2ANDA089351ROXICETROXANE LABORATORIES INC1986-12-03ANDA089351_001
3ANDA203573OXYCODONE HYDROCHLORIDE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS2014-12-18ANDA203573_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040680_001discontinuedACETAMINOPHEN (325MG/5ML), OXYCODONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONFalse2006-09-29OXYCODONE AND ACETAMINOPHEN
2ANDA089351_001RXACETAMINOPHEN (325MG/5ML), OXYCODONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONTrueAA1986-12-03ROXICET
3ANDA203573_001RXOXYCODONE HYDROCHLORIDE (5MG/5ML), ACETAMINOPHEN (325MG/5ML)ORALSOLUTIONFalseAA2014-12-18OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11affabf4-d808-4dc4-ad48-ea4fc9b3c28d (view SPL)OXYCODONE AND ACETAMINOPHEN ORAL SOLUTION (5 mg/325 mg per 5 mL) Rx only CIIprescriptionHuman PrescriptionMallinckrodt, Inc.2013-11-047004068553
286817b05-450c-4af0-aeea-acba2ac00601 (view SPL)ROXICET CII Oxycodone 5 mg and Acetaminophen 325 mg Tablets, USP Oxycodone 5 mg and Acetaminophen 325 mg Oral Solution per 5 mLprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2014-07-0213000543686, 000548648, 000544650, 000548650Acetaminophen / Oxycodone Oral Tablet
38f0eccce-728f-4039-959b-4887ae32325f (view SPL)OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION5 mg/325 mg per 5 mLCIIRx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2014-02-053006031492

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