FDA.reportPublic FDA data

Application 201821

Type
ANDA
Sponsor
LYNE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTION;ORALEQ 75MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0374-5070CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDELyne Laboratories, Inc.ANDACurrent
63629-2391CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2391CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
64980-511CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDERising Pharmaceuticals, Inc.ANDACurrent
64980-511CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDERising Pharmaceuticals, Inc.ANDACurrent
64980-511CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDERising Pharmaceuticals, Inc.ANDACurrent