FDA.reportPublic FDA data

Application 065022

Type
ANDA
Sponsor
PERRIGO CO TENNESSEE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACITRACIN ZINC AND POLYMYXIN B SULFATEBACITRACIN ZINC; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC500 UNITS/GM;10,000 UNITS/GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0273Bacitracin Zinc and Polymyxin B SulfateBacitracin Zinc and Polymyxin B SulfateE. FOUGERA & CO., A division of Nycomed US Inc.ANDACurrent
0574-4021polycinbacitracin zinc and polymyxin b sulfatesPadagis US LLCANDACurrent
0574-4021polycinbacitracin zinc and polymyxin b sulfatesPaddock Laboratories, LLCANDACurrent
50090-1653polycinbacitracin zinc and polymyxin b sulfatesA-S Medication SolutionsANDACurrent
50090-1653polycinbacitracin zinc and polymyxin b sulfatesA-S Medication SolutionsANDACurrent
53002-9270polycinbacitracin zinc and polymyxin b sulfatesRPK Pharmaceuticals, Inc.ANDACurrent
53002-9270polycinbacitracin zinc and polymyxin b sulfatesRPK Pharmaceuticals, Inc.ANDACurrent
61919-111POLYCINbacitracin zinc and polymyxin b sulfatesDIRECT RXANDACurrent
61919-111POLYCINbacitracin zinc and polymyxin b sulfatesDIRECT RXANDACurrent
66267-925polycinbacitracin zinc and polymyxin b sulfatesNuCare Pharmaceuticals,InANDACurrent
66267-925polycinbacitracin zinc and polymyxin b sulfatesNuCare Pharmaceuticals,Inc.ANDACurrent
66267-925polycinbacitracin zinc and polymyxin b sulfatesNuCare Pharmaceuticals,Inc.ANDACurrent