FDA.reportPublic FDA data

Application 208151

Type
NDA
Sponsor
ALCON LABS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0303Isopto Atropineatropine sulfateAlcon Laboratories, Inc.NDACurrent
0065-0303Isopto Atropineatropine sulfateAlcon Laboratories, Inc.NDACurrent
0065-0303Isopto Atropineatropine sulfateAlcon Laboratories, Inc.NDACurrent
0065-0303Isopto Atropineatropine sulfateAlcon Laboratories, Inc.NDACurrent
0065-0303Isopto Atropineatropine sulfateAlcon Laboratories, Inc.NDACurrent
0065-0817atropine sulfateatropine sulfateAlcon Laboratories, Inc.NDACurrent
0065-0817atropine sulfateatropine sulfateAlcon Laboratories, Inc.NDACurrent
0065-0817atropine sulfateatropine sulfateAlcon Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71806SUPPL2022-08-15
71798SUPPL2022-08-15
47583ORIG2017-03-17
46024ORIG2016-12-06
46013ORIG2016-12-05
51754ORIG1900-01-01
51753ORIG1900-01-01
51752ORIG1900-01-01