FDA.reportPublic FDA data

Application 201746

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINCOMYCINLINCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 300MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9901LINCOMYCINlincomycin hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9901LINCOMYCINlincomycin hydrochlorideHenry Schein, Inc.ANDACurrent
39822-0350Lincomycinlincomycin hydrochlorideXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0350Lincomycinlincomycin hydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0350Lincomycinlincomycin hydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0350Lincomycinlincomycin hydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0350Lincomycinlincomycin hydrochlorideXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0353Lincomycinlincomycin hydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0353Lincomycinlincomycin hydrochlorideXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0353Lincomycinlincomycin hydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0353Lincomycinlincomycin hydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0353Lincomycinlincomycin hydrochlorideXGen Pharmaceuticals DJB, Inc.ANDACurrent
50090-4533Lincomycinlincomycin hydrochlorideA-S Medication SolutionsANDACurrent
50090-4533Lincomycinlincomycin hydrochlorideA-S Medication SolutionsANDACurrent
52584-353LINCOMYCINlincomycin hydrochlorideGeneral Injectables and Vaccines, INC.ANDACurrent
52584-353LINCOMYCINlincomycin hydrochlorideGeneral Injectables and Vaccines, INC.ANDACurrent
52584-353LINCOMYCINlincomycin hydrochlorideGeneral Injectables and Vaccines, INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32136ORIG2015-06-10