FDA.report

Application 201821

Type
ANDA
Sponsor
LYNE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTION;ORALEQ 75MG BASE/5MLNoNo

NDC Listings For This Application

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