FDA.reportPublic FDA data

Application 020226

Type
NDA
Sponsor
ALCON

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0085Naphcon Anaphazoline hydrochloride and pheniramine maleateAlcon Laboratories, Inc.NDACurrent
0065-0085Naphcon Anaphazoline hydrochloride and pheniramine maleateAlcon Laboratories, Inc.NDACurrent
0065-0085Naphcon Anaphazoline hydrochloride and pheniramine maleateAlcon Laboratories, Inc.NDACurrent
0065-0085Naphcon Anaphazoline hydrochloride and pheniramine maleateAlcon Laboratories, Inc.NDACurrent
0065-0085Naphcon Anaphazoline hydrochloride and pheniramine maleateAlcon Laboratories, Inc.NDACurrent
0065-0085Naphcon Anaphazoline hydrochloride and pheniramine maleateAlcon Laboratories, Inc.NDACurrent
50090-0185Naphcon Anaphazoline hydrochloride and pheniramine maleateA-S Medication SolutionsNDACurrent
50090-0185Naphcon Anaphazoline hydrochloride and pheniramine maleateA-S Medication SolutionsNDACurrent
50090-0185Naphcon Anaphazoline hydrochloride and pheniramine maleateA-S Medication SolutionsNDACurrent
52959-107NAPHCON ANAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEH.J. Harkins Company, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72974SUPPL2022-12-21
72955SUPPL2022-12-20
58325SUPPL2019-04-15
58318SUPPL2019-04-12