FDA.reportPublic FDA data

Application 078208

Type
ANDA
Sponsor
ALTAIRE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATENAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATESOLUTION/DROPS;OPHTHALMIC0.02675%;0.315%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49035-874Equate Eye Allergy Relief DropsNAPHAZOLINE HYDROCHLORIDE, Pheniramine MaleateWal-Mart Stores, Inc.ANDACurrent
59390-177Naphazoline HCI And Pheniramine MaleateNAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATEAltaire Pharmaceuticals Inc.ANDACurrent
59390-177Naphazoline HCI And Pheniramine MaleateNAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATEAltaire Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43136ORIG2013-01-30