FDA.reportPublic FDA data

Application 203513

Type
ANDA
Sponsor
AMNEAL PHARMS

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
10135-569Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-569Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideMarlex Pharmaceuticals IncANDACurrent
65162-468Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-468Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-468Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-468Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-468Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-468Clindamycin Palmitate HydrochlorideClindamycin Palmitate HydrochlorideAmneal Pharmaceuticals LLCANDACurrent