FDA.reportPublic FDA data

Application 050790

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RESTASISCYCLOSPORINEEMULSION;OPHTHALMIC0.05%YesYes
002RESTASIS MULTIDOSECYCLOSPORINEEMULSION;OPHTHALMIC0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5301Restasis MultiDosecyclosporineAllergan, Inc.NDACurrent
0023-5301Restasis MultiDosecyclosporineAllergan, Inc.NDACurrent
0023-5301Restasis MultiDosecyclosporineAllergan, Inc.NDACurrent
0023-9163RESTASIScyclosporineAllergan, Inc.NDACurrent
0023-9163RESTASIScyclosporineAllergan, Inc.NDACurrent
0023-9163RESTASIScyclosporineAllergan, Inc.NDACurrent
0023-9163RESTASIScyclosporineAllergan, Inc.NDACurrent
0023-9163RESTASIScyclosporineAllergan, Inc.NDACurrent
10702-808CyclosporineCyclosporineKVK-TECH, INC.NDA AUTHORIZED GENERICCurrent
50090-1242RESTASIScyclosporineA-S Medication SolutionsNDACurrent
50090-1242RESTASIScyclosporineA-S Medication SolutionsNDACurrent
50090-1242RESTASIScyclosporineA-S Medication SolutionsNDACurrent
50090-4476RESTASIScyclosporineA-S Medication SolutionsNDACurrent
50090-4476RESTASIScyclosporineA-S Medication SolutionsNDACurrent
50090-5977CyclosporineCyclosporineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
60505-6202CyclosporineCyclosporineApotex CorpNDA AUTHORIZED GENERICCurrent
68180-214CYCLOSPORINEcyclosporineLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83192SUPPL 2025-08-26
83175SUPPL 2025-08-22
57214SUPPL2019-01-14
57213SUPPL2019-01-14
49033SUPPL2017-07-21
49018SUPPL2017-07-19
46103SUPPL2016-12-09
46102SUPPL2016-12-09
18253SUPPL2013-06-04
8296SUPPL2012-12-05
39338SUPPL2012-12-04
22240SUPPL2007-06-11
42740ORIG2005-04-14
30549SUPPL2003-10-01
8295SUPPL2003-10-01
18252SUPPL2003-09-26
8294SUPPL2003-09-25
30548ORIG2003-09-08
18251ORIG2003-09-08