FDA.reportPublic FDA data

Application 040277

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPARACAINE HYDROCHLORIDEPROPARACAINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.5%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-7199Proparacaine HydrochlorideProparacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-7199Proparacaine HydrochlorideProparacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-7199Proparacaine HydrochlorideProparacaine HydrochlorideHenry Schein Inc.ANDACurrent
13985-611Proparacaine HydrochlorideProparacaine HydrochlorideMWIANDACurrent
13985-611Proparacaine HydrochlorideProparacaine HydrochlorideMWIANDACurrent
13985-611Proparacaine HydrochlorideProparacaine HydrochlorideMWIANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkornANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkornANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkorn, Inc.ANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkorn, Inc.ANDACurrent
50090-0259Proparacaine HydrochlorideProparacaine HydrochlorideA-S Medication SolutionsANDACurrent
70518-2056Proparacaine HydrochlorideProparacaine HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17762ORIG2004-06-14
22112ORIG2003-07-31
7601ORIG2000-03-16