FDA.reportPublic FDA data

Application 020065

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPCON-ANAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATESOLUTION/DROPS;OPHTHALMIC0.02675%;0.315%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-9652Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-9652Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11822-0552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-0552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-0552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-3865Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-3865Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
24208-430Opcon-ANaphazoline hydrochloride and Pheniramine maleateBausch & Lomb IncorporatedNDACurrent
24208-430Opcon-ANaphazoline hydrochloride and Pheniramine maleateBausch & Lomb IncorporatedNDACurrent
24208-430Opcon-ANaphazoline hydrochloride and Pheniramine maleateBausch & Lomb IncorporatedNDACurrent
49035-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWal-Mart Stores IncNDACurrent
49035-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWal-Mart Stores IncNDACurrent
49035-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWal-Mart Stores IncNDACurrent
55910-552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideDOLGENCORP, LLCNDACurrent
55910-552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideDOLGENCORP, LLCNDACurrent
59779-042Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideCVS PharmacyNDACurrent
59779-552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideCVS PharmacyNDACurrent
69842-441EYE ALLERGY RELIEFNaphazoline hydrochloride and Pheniramine maleateCVS PHARMACYNDACurrent
70518-0475Opcon-ANaphazoline hydrochloride and Pheniramine maleateREMEDYREPACK INC.NDACurrent
70518-0475Opcon-ANaphazoline hydrochloride and Pheniramine maleateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72245SUPPL2022-10-05
72152SUPPL2022-09-26
12166SUPPL2007-08-02
1964SUPPL2007-08-02
1963SUPPL2005-04-28