FDA.reportPublic FDA data

Application 020485

Type
NDA
Sponsor
JOHNSON AND JOHNSON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VISINENAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATESOLUTION/DROPS;OPHTHALMIC0.025%;0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42002-200Visine ANaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0063Visine ANaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0063Visine ANaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0367Visine Allergy Eye Relief Multi-ActionNaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0367Visine Allergy Eye Relief Multi-ActionNaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0367Visine Allergy Eye Relief Multi-ActionNaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
70518-0817Visine ANaphazoline Hydrochloride and Pheniramine MaleateREMEDYREPACK INC.NDACurrent
70518-1729Visine ANaphazoline Hydrochloride and Pheniramine MaleateREMEDYREPACK INC.NDACurrent
70518-1729Visine ANaphazoline Hydrochloride and Pheniramine MaleateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83903SUPPL 2025-10-23
83901SUPPL 2025-10-23
56099SUPPL2018-10-26
56056SUPPL2018-10-23
45179SUPPL2016-08-26
12628SUPPL2014-01-14
25031SUPPL2012-12-21
2593SUPPL2004-10-22
34699SUPPL2003-09-25
25030SUPPL2003-09-25
25029SUPPL2002-06-14
12627SUPPL2002-06-14