FDA.reportPublic FDA data

Application 201692

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 6MG BASE/MLNoNo
002CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 12MG BASE/MLNoNo
003CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATEINJECTABLE;INJECTIONEQ 18MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3288Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3288Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3288Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3288Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3288Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3288Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3289Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3289Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3289Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3289Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3289Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3289Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3290Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3290Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3290Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3290Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3290Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-3290Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9220Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9220Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9220Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9220Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9220Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9220Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9221Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9221Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9221Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9221Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9221Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9221Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9222Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9222Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9222Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9222Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9222Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
0781-9222Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseSandoz IncANDACurrent
72572-074Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseCivica, Inc.ANDACurrent
72572-074Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseCivica, Inc.ANDACurrent
72572-074Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseCivica, Inc.ANDACurrent
72572-076Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseCivica, Inc.ANDACurrent
72572-076Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseCivica, Inc.ANDACurrent
72572-076Clindamycin in 5 Percent DextroseClindamycin in 5 Percent DextroseCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43371ORIG2012-10-09