Levorphanol Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sentynl Therapeutics, Inc. (2015-05-28)
Oldest Current Product
2000-03-31
License(s)
ANDA
RxNORM
ORAL TABLET\LEVORPHANOL
FDAOB
ORAL\TABLET\LEVORPHANOL TARTRATE
SPL Active
ORAL\TABLET\LEVORPHANOL TARTRATE
SPL Moiety
ORAL\TABLET\LEVORPHANOL

product(s) by strength(s)

levorphanol 2 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540438ANDARoxane Laboratories, Inc2000-03-31LEVORPHANOL TARTRATEORALTABLETANDA074278b2ab70e4-ca0c-4a73-9c98-974bf94e890c
2423580102ANDASentynl Therapeutics, Inc.2015-05-28LEVORPHANOL TARTRATEORALTABLETANDA07427877f4a54a-6901-46d9-93db-ad4be7eae6c3

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074278LEVORPHANOL TARTRATESENTYNL THERAPEUTICS INC2000-03-31ANDA074278_001
2NDA008720LEVO-DROMORANTrueVALEANT PHARMACEUTICALS INTERNATIONAL1991-12-19NDA008720_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074278_001RXLEVORPHANOL TARTRATE (2MG)ORALTABLETTrue2000-03-31LEVORPHANOL TARTRATE
2NDA008720_001discontinuedLEVORPHANOL TARTRATE (2MG)ORALTABLETFalse1991-12-19LEVO-DROMORAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
177f4a54a-6901-46d9-93db-ad4be7eae6c3 (view SPL)prescriptionHuman PrescriptionSentynl Therapeutics, Inc.MANUFACTURE2015-05-282423580102
2b2ab70e4-ca0c-4a73-9c98-974bf94e890c (view SPL)LEVORPHANOL TARTRATE TABLETS USP, 2 mg, CIIprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-09-177000540438

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