FDA.reportPublic FDA data

Application 022315

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OZURDEXDEXAMETHASONEIMPLANT;INTRAVITREAL0.7MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-3348OZURDEXdexamethasoneAllergan, Inc.NDACurrent
0023-3348OZURDEXdexamethasoneAllergan, Inc.NDACurrent
0023-3348OZURDEXdexamethasoneAllergan, Inc.NDACurrent
0023-3348OZURDEXdexamethasoneAllergan, Inc.NDACurrent
0023-3348OZURDEXdexamethasoneAllergan, Inc.NDACurrent
0023-3348OZURDEXdexamethasoneAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85371SUPPL 2026-03-12
85358SUPPL 2026-03-12
84936SUPPL 2026-02-05
72977SUPPL2022-12-21
72965SUPPL2022-12-21
65020SUPPL2020-10-23
64983SUPPL2020-10-23
54233SUPPL2018-05-17
54216SUPPL2018-05-16
48435SUPPL2017-05-17
29586SUPPL2014-10-01
38565SUPPL2014-09-30
38564SUPPL2014-07-01
29585SUPPL2014-06-30
7226SUPPL2014-02-11
17235SUPPL2014-02-10
38563SUPPL2012-09-11
7225SUPPL2012-09-10
7224SUPPL2012-02-29
38562SUPPL2012-02-28
38561SUPPL2010-09-29
29584SUPPL2010-09-29
29583SUPPL2010-09-07
44737ORIG2009-10-29
42490ORIG2009-10-29
7223ORIG2009-06-23
17234ORIG2009-06-22