FDA.reportPublic FDA data

Application 206289

Type
NDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPINE SULFATEATROPINE SULFATESOLUTION/DROPS;OPHTHALMIC1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13985-606AtropineAtropine SulfateMWINDACurrent
13985-606AtropineAtropine SulfateMWINDACurrent
13985-606AtropineAtropine SulfateMWINDACurrent
13985-606AtropineAtropine SulfateMWINDACurrent
17478-215AtropineAtropine SulfateAkorn, Inc.NDACurrent
17478-215AtropineAtropine SulfateAkornNDACurrent
17478-215AtropineAtropine SulfateAkornNDACurrent
17478-215AtropineAtropine SulfateAkorn, Inc.NDACurrent
17478-215AtropineAtropine SulfateAkornNDACurrent
50090-3104AtropineAtropine SulfateA-S Medication SolutionsNDACurrent
50090-3104AtropineAtropine SulfateA-S Medication SolutionsNDACurrent
50090-6295AtropineAtropine SulfateA-S Medication SolutionsNDACurrent
76478-015AtropineAtropine SulfateAkornNDACurrent
76478-015AtropineAtropine SulfateAkornNDACurrent
76478-015AtropineAtropine SulfateAkornNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83405SUPPL 2025-09-19
83394SUPPL 2025-09-19
71135SUPPL2022-05-23
70573SUPPL2022-03-21
44940ORIG2015-04-07
43512ORIG2015-04-07
32791ORIG2014-07-23
19712ORIG2014-07-23
51757ORIG1900-01-01
51756ORIG1900-01-01
51755ORIG1900-01-01