calcipotriene Topical Solution

Brand(s)
Dovonex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Global Pharmaceuticals (2012-09-10)
Oldest Current Product
1997-06-01
License(s)
NDA, ANDA
RxNORM
TOPICAL SOLUTION\CALCIPOTRIENE
FDAOB
TOPICAL\SOLUTION\CALCIPOTRIENE
SPL Active
TOPICAL\SOLUTION\CALCIPOTRIENE
TOPICAL\SOLUTION\CALCIPOTRIENE HYDRATE
SPL Moiety
TOPICAL\SOLUTION\CALCIPOTRIENE

product(s) by strength(s)

calcipotriene 0.05 mg/ml topical solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151475ANDAGlobal Pharmaceuticals2009-11-20CALCIPOTRIENETOPICALSOLUTIONANDA077029bf9ea848-3138-4f2d-9bc0-75b470a51d5c
2001680400ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2008-05-06CALCIPOTRIENETOPICALSOLUTIONANDA078305fff63bc7-6b92-4080-9a11-017124d95162
3007130318ANDAG&W Laboratories, Inc.2011-04-04CALCIPOTRIENETOPICALSOLUTIONANDA07846821378c25-5622-8bf7-1a8c-b05940a846a0
4503830732ANDAHi-Tech Pharmacal Co., Inc.2014-10-06CALCIPOTRIENE HYDRATETOPICALSOLUTIONANDA07757953c9942a-e861-493f-95c2-53446bc5f06d

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004303030DovonexNDAWarner Chilcott (Us), Llc2006-01-01CALCIPOTRIENETOPICALSOLUTIONNDA020611ac6739cd-df1b-45ce-b6fd-ba83815d0f68
2502220403DovonexNDALeo Pharma Inc.1997-06-01CALCIPOTRIENETOPICALSOLUTIONNDA02061192d53473-e33d-4490-9390-ec333dbf7676
3548686057DovonexNDAPhysicians Total Care, Inc.2009-08-12CALCIPOTRIENETOPICALSOLUTION004303030NDA0206111c02cc96-ecaa-467b-9acb-7cae57ec8e87

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA077029CALCIPOTRIENETOLMAR INC2009-11-20ANDA077029_001
2ANDA077579CALCIPOTRIENEHI TECH PHARMACAL CO INC2009-11-19ANDA077579_001
3ANDA078305CALCIPOTRIENEFOUGERA PHARMACEUTICALS INC2008-05-06ANDA078305_001
4ANDA078468CALCIPOTRIENEG AND W LABORATORIES INC2011-03-24ANDA078468_001
5NDA020611DOVONEXTrueLEO PHARMACEUTICAL PRODUCTS LTD1997-03-03pRE39706, SUBSTANCE
p5763426, SUBSTANCE
NDA020611_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077029_001RXCALCIPOTRIENE (0.005%)TOPICALSOLUTIONTrueAT2009-11-20CALCIPOTRIENE
2ANDA077579_001RXCALCIPOTRIENE (0.005%)TOPICALSOLUTIONFalseAT2009-11-19CALCIPOTRIENE
3ANDA078305_001RXCALCIPOTRIENE (0.005%)TOPICALSOLUTIONFalseAT2008-05-06CALCIPOTRIENE
4ANDA078468_001RXCALCIPOTRIENE (0.005%)TOPICALSOLUTIONFalseAT2011-03-24CALCIPOTRIENE
5NDA020611_001discontinuedCALCIPOTRIENE (0.005%)TOPICALSOLUTIONFalse1997-03-03DOVONEX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5763426 (view patent)2015-06-09NDA020611, NDA020554, NDA021852Betamethasone / calcipotriene Topical Ointment
calcipotriene Topical Cream
2pRE39706 (view patent)2015-06-09NDA020611, NDA020554, NDA021852, NDA022185Betamethasone / calcipotriene Topical Ointment
calcipotriene Topical Cream
Betamethasone / calcipotriene Topical Lotion

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11c02cc96-ecaa-467b-9acb-7cae57ec8e87 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-09-144548686057
221378c25-5622-8bf7-1a8c-b05940a846a0 (view SPL)Calcipotriene Topical Solution, 0.005%(Scalp Solution) FOR TOPICAL DERMATOLOGIC USE ONLY.Not for Ophthalmic, Oral or Intravaginal Use. Rx onlyprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2011-04-043007130318
353c9942a-e861-493f-95c2-53446bc5f06d (view SPL)Calcipotriene Topical Solution, 0.005% (Scalp Solution)prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2014-10-064503830732
492d53473-e33d-4490-9390-ec333dbf7676 (view SPL)Dovonex (calcipotriene solution) Scalp Solution, 0.005%prescriptionHuman PrescriptionLeo Pharma Inc.MANUFACTURE2011-04-254502220403
5ac6739cd-df1b-45ce-b6fd-ba83815d0f68 (view SPL)Dovonex (calcipotriene solution) Scalp Solution, 0.005%prescriptionHuman PrescriptionWarner Chilcott (Us), LlcMANUFACTURE2009-11-254004303030
6bf9ea848-3138-4f2d-9bc0-75b470a51d5c (view SPL)Calcipotriene Topical Solution, 0.005% (Scalp Solution)prescriptionHuman PrescriptionGlobal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2012-09-102001151475
7fff63bc7-6b92-4080-9a11-017124d95162 (view SPL)CALCIPOTRIENE TOPICAL SOLUTION 0.005% (Scalp Solution)prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-06-233001680400

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