Methoxsalen Oral Capsule

Brand(s)
8-MOP, Oxsoralen-Ultra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oceanside Pharmaceuticals (2015-03-02)
Oldest Current Product
1986-10-30
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\METHOXSALEN
FDAOB
ORAL\CAPSULE\METHOXSALEN
TOPICAL\LOTION\METHOXSALEN
SPL Active
ORAL\CAPSULE, LIQUID FILLED\METHOXSALEN
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\METHOXSALEN

product(s) by strength(s)

methoxsalen 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001870650Oxsoralen-UltraNDAValeant Pharmaceuticals North America Llc1986-10-30METHOXSALENORALCAPSULE, LIQUID FILLEDNDA019600ae951dc4-9031-43bf-943c-cb2366951f23

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1459630325ANDAActavis Inc.2015-08-15METHOXSALENORALCAPSULE, LIQUID FILLEDANDA202603c6432c42-e53d-4077-bf7b-f33349349de6
2643800752ANDAStrides Arcolab Limited2014-06-13METHOXSALENORALCAPSULE, LIQUID FILLEDANDA202687a6ec8292-9189-4ebd-862a-e1725eb29eef
3686820065NDA AUTHORIZED GENERICOceanside Pharmaceuticals2014-07-15METHOXSALENORALCAPSULE, LIQUID FILLEDNDA01960028cdcef9-0623-4c5a-bd18-aa3d2a3d40f8

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA087781METHOXSALENTrueSANDOZ INC1982-06-08ANDA087781_001Methoxsalen Topical Lotion
2ANDA202603METHOXSALENACTAVIS INC2015-06-09ANDA202603_001Methoxsalen Topical Lotion
3ANDA202687METHOXSALENSTRIDES PHARMA GLOBAL PTE LTD2014-06-05ANDA202687_001Methoxsalen Topical Lotion
4NDA0090488-MOPVALEANT PHARMACEUTICALS INTERNATIONALNDA009048_001, NDA009048_002Methoxsalen Topical Lotion
5NDA019600OXSORALEN-ULTRADOW PHARMACEUTICAL SCIENCES1986-10-30NDA019600_001Methoxsalen Topical Lotion

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA087781_001discontinuedMETHOXSALEN (10MG)ORALCAPSULEFalse1982-06-08METHOXSALEN
2ANDA202603_001RXMETHOXSALEN (10MG)ORALCAPSULEFalseAB2015-06-09METHOXSALEN
3ANDA202687_001RXMETHOXSALEN (10MG)ORALCAPSULEFalseAB2014-06-05METHOXSALEN
4NDA009048_001RXMETHOXSALEN (10MG)ORALCAPSULETrue8-MOP
5NDA009048_002RXMETHOXSALEN (1%)TOPICALLOTIONTrue8-MOP
6NDA019600_001RXMETHOXSALEN (10MG)ORALCAPSULETrueAB1986-10-30OXSORALEN-ULTRA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
128cdcef9-0623-4c5a-bd18-aa3d2a3d40f8 (view SPL)Methoxsalen Capsules, USP, 10 mgprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-03-022686820065
2a4c61db9-b72d-4b67-b69b-a97257b614ad (view SPL)8-MOP CAPSULES(Methoxsalen Capsules, USP, 10 mg)prescriptionHuman PrescriptionValeant Pharmaceuticals North America Llc2010-08-304001870651
3a6ec8292-9189-4ebd-862a-e1725eb29eef (view SPL)Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]prescriptionHuman PrescriptionStrides Arcolab LimitedAnalysis, Manufacture, Pack2014-06-303643800752
4ae951dc4-9031-43bf-943c-cb2366951f23 (view SPL)OXSORALEN-ULTRA CAPSULES(Methoxsalen Capsules, USP, 10 mg)Rx onlyprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-03-025001870650
5c6432c42-e53d-4077-bf7b-f33349349de6 (view SPL)Methoxsalen Capsules, USPprescriptionHuman PrescriptionActavis Inc.ANALYSIS, MANUFACTURE, PACK2015-05-184459630325

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