Meperidine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2012-04-18)
Oldest Current Product
1985-01-30
License(s)
ANDA
RxNORM
ORAL SOLUTION\MEPERIDINE
FDAOB
INJECTION\INJECTION\MEPERIDINE HYDROCHLORIDE\rdfq
ORAL\SYRUP\MEPERIDINE HYDROCHLORIDE
ORAL\TABLET\MEPERIDINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\MEPERIDINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\MEPERIDINE

product(s) by strength(s)

meperidine hydrochloride 10 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543545ANDARoxane Laboratories, Inc1985-01-30MEPERIDINE HYDROCHLORIDEORALSOLUTIONANDA08874415bc51a8-1e24-4d33-9a2f-05a41c29acf0

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA088744MEPERIDINE HYDROCHLORIDEROXANE LABORATORIES INC1985-01-30ANDA088744_001Meperidine Oral Tablet
2NDA005010DEMEROLSANOFI AVENTIS US LLCNDA005010_001, NDA005010_002, NDA005010_003, NDA005010_004, NDA005010_005, NDA005010_007, NDA005010_009Meperidine Oral Tablet
Meperidine Injectable Solution
Meperidine Injection
Meperidine Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA088744_001RXMEPERIDINE HYDROCHLORIDE (50MG/5ML)ORALSYRUPTrue1985-01-30MEPERIDINE HYDROCHLORIDE
2NDA005010_001RXMEPERIDINE HYDROCHLORIDE (50MG)ORALTABLETTrueAADEMEROL
3NDA005010_002discontinuedMEPERIDINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseDEMEROL
4NDA005010_003discontinuedMEPERIDINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseDEMEROL
5NDA005010_004RXMEPERIDINE HYDROCHLORIDE (100MG)ORALTABLETTrueAADEMEROL
6NDA005010_005discontinuedMEPERIDINE HYDROCHLORIDE (50MG/5ML)ORALSYRUPFalseDEMEROL
7NDA005010_007discontinuedMEPERIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseDEMEROL
8NDA005010_009discontinuedMEPERIDINE HYDROCHLORIDE (75MG/ML)INJECTIONFalseDEMEROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
115bc51a8-1e24-4d33-9a2f-05a41c29acf0 (view SPL)MEPERIDINE HYDROCHLORIDE Tablets USP CII MEPERIDINE HYDROCHLORIDE Oral Solution USP CIIprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-04-184000543545, 000544595, 000544596, 000548595Meperidine Oral Tablet

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