FDA.reportPublic FDA data

Application 204398

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDESOLUTION;OPHTHALMIC1%NoNo
002PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDESOLUTION;OPHTHALMIC2%NoNo
003PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDESOLUTION;OPHTHALMIC4%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-223Pilocarpine HydrochloridePilocarpine HydrochlorideAkornANDACurrent
17478-223Pilocarpine HydrochloridePilocarpine HydrochlorideAkorn, Inc.ANDACurrent
17478-223Pilocarpine HydrochloridePilocarpine HydrochlorideAkorn, Inc.ANDACurrent
17478-223Pilocarpine HydrochloridePilocarpine HydrochlorideAkornANDACurrent
17478-224Pilocarpine HydrochloridePilocarpine HydrochlorideAkornANDACurrent
17478-224Pilocarpine HydrochloridePilocarpine HydrochlorideAkorn, Inc.ANDACurrent
17478-224Pilocarpine HydrochloridePilocarpine HydrochlorideAkorn, Inc.ANDACurrent
17478-224Pilocarpine HydrochloridePilocarpine HydrochlorideAkornANDACurrent
17478-226Pilocarpine HydrochloridePilocarpine HydrochlorideAkornANDACurrent
17478-226Pilocarpine HydrochloridePilocarpine HydrochlorideAkorn, Inc.ANDACurrent
17478-226Pilocarpine HydrochloridePilocarpine HydrochlorideAkorn, Inc.ANDACurrent
17478-226Pilocarpine HydrochloridePilocarpine HydrochlorideAkornANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49892ORIG2017-09-29