Application 016750

Type
NDA
Sponsor
AMPHASTAR PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CORTROSYNCOSYNTROPININJECTABLE;INJECTION0.25MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9839CortrosynCortrosynHenry Schein, Inc.NDACurrent
0404-9839CortrosynCortrosynHenry Schein, Inc.NDACurrent
0548-5900CortrosynCosyntropinAmphastar Pharmaceuticals, Inc.NDACurrent
0548-5900CortrosynCosyntropinAmphastar Pharmaceuticals, Inc.NDACurrent
50090-4547CortrosynCosyntropinA-S Medication SolutionsNDACurrent
52584-050CortrosynCortrosynGeneral Injectables & Vaccines, IncNDACurrent
52584-050CortrosynCortrosynGeneral Injectables & Vaccines, IncNDACurrent
52584-050CortrosynCortrosynGeneral Injectables & Vaccines, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77154SUPPL 2023-12-27
77128SUPPL 2023-12-27
69579SUPPL2021-12-16
69578SUPPL2021-12-16
490SUPPL2002-11-08