FDA.reportPublic FDA data

Application 207926

Type
NDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC2.5%YesYes
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC10%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-201Phenylephrine HydrochloridePhenylephrine HydrochlorideAkornNDACurrent
17478-201Phenylephrine HydrochloridePhenylephrine HydrochlorideAkornNDACurrent
17478-201Phenylephrine HydrochloridePhenylephrine HydrochlorideAkorn, Inc.NDACurrent
17478-201Phenylephrine HydrochloridePhenylephrine HydrochlorideAkorn, Inc.NDACurrent
17478-201Phenylephrine HydrochloridePhenylephrine HydrochlorideAkornNDACurrent
17478-206Phenylephrine HydrochloridePhenylephrine HydrochlorideAkornNDACurrent
17478-206Phenylephrine HydrochloridePhenylephrine HydrochlorideAkornNDACurrent
17478-206Phenylephrine HydrochloridePhenylephrine HydrochlorideAkorn, Inc.NDACurrent
17478-206Phenylephrine HydrochloridePhenylephrine HydrochlorideAkorn, Inc.NDACurrent
17478-206Phenylephrine HydrochloridePhenylephrine HydrochlorideAkornNDACurrent
50090-4514Phenylephrine HydrochloridePhenylephrine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4514Phenylephrine HydrochloridePhenylephrine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4514Phenylephrine HydrochloridePhenylephrine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4515Phenylephrine HydrochloridePhenylephrine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4515Phenylephrine HydrochloridePhenylephrine HydrochlorideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57903SUPPL2019-03-05
57884SUPPL2019-03-04
43537ORIG2015-04-13
10627ORIG2015-01-21
19974ORIG2015-01-20