FDA.reportPublic FDA data

Application 078434

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-209Ketorolac Tromethamineketorolac tromethamineAkornANDACurrent
17478-209Ketorolac Tromethamineketorolac tromethamineAkorn Inc.ANDACurrent
17478-209Ketorolac Tromethamineketorolac tromethamineAkorn Inc.ANDACurrent
35356-771Ketorolac Tromethamineketorolac tromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1142Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50436-6195Ketorolac Tromethamineketorolac tromethamineUnit Dose ServicesANDACurrent
63187-628Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
63187-628Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
63187-628Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
68071-2400Ketorolac Tromethamineketorolac tromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9321Ketorolac Tromethamineketorolac tromethaminePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31367ORIG2009-11-12