FDA.reportPublic FDA data

Application 021119

Type
NDA
Sponsor
VALEANT LUXEMBOURG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VISUDYNEVERTEPORFININJECTABLE;INJECTION15MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5600Visudyneverteporfin for injectionBausch Health US LLCNDACurrent
0187-5600Visudyneverteporfin for injectionBausch Health US LLCNDACurrent
0187-5600Visudyneverteporfin for injectionBausch Health US LLCNDACurrent
0187-5600Visudyneverteporfin for injectionValeant Pharmaceuticals NNDACurrent
0187-5600Visudyneverteporfin for injectionBausch Health US LLCNDACurrent
0187-5600Visudyneverteporfin for injectionValeant Pharmaceuticals North America LLCNDACurrent
0187-5600Visudyneverteporfin for injectionBausch Health US LLCNDACurrent
50236-001Visudyneverteporfin for injectionQLT Ophthalmics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73499SUPPL 2023-02-14
73457SUPPL 2023-02-13
68061SUPPL2021-07-13
68053SUPPL2021-07-12
36155SUPPL2016-05-17
26818SUPPL2016-05-12
26817SUPPL2012-06-29
14428SUPPL2012-06-29
4376SUPPL2008-07-01
14426SUPPL2008-06-30
4377SUPPL2007-04-09
14427SUPPL2007-03-31
36154SUPPL2005-03-30
26816SUPPL2005-03-30
41962SUPPL2005-03-08
41961SUPPL2005-03-08
26815SUPPL2004-03-02
4375SUPPL2004-03-02
4374SUPPL2002-12-09
14425SUPPL2002-11-25
36153SUPPL2002-05-29
26814SUPPL2002-05-29
26813SUPPL2002-04-30
14424SUPPL2002-04-30
26812SUPPL2001-08-22
21459SUPPL2001-08-22
14423SUPPL2001-08-22
41960ORIG2000-04-12
14422ORIG2000-04-12
4373ORIG2000-04-12