Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Product Details
NDC Product Code
72189-017Application Number
ANDA064046Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
July 24, 2019BacitracinActive
Code: 89Y4M234ESClass: ACTIMQuantity: 500 [USP'U] in 1 g
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
Polymyxin BActive
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 g