Application 212291

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMOLOL MALEATETIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 0.5% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-189Timolol MaleateTimololAkornANDACurrent
17478-189Timolol MaleateTimololAkornANDACurrent
17478-189Timolol MaleateTimololAkorn, Inc.ANDACurrent
17478-189Timolol MaleateTimololAkorn, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65099ORIG2020-10-30