FDA.reportPublic FDA data

Application 063029

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoNo
002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-3171Clindamycin HydrochlorideClindamycin HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-3171Clindamycin HydrochlorideClindamycin HydrochlorideG&W Laboratories, Inc.ANDACurrent
0713-3171Clindamycin HydrochlorideClindamycin HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-3171Clindamycin HydrochlorideClindamycin HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-5256Clindamycin HydrochlorideClindamycin HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-5256Clindamycin HydrochlorideClindamycin HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-5256Clindamycin HydrochlorideClindamycin HydrochlorideG&W Laboratories, Inc.ANDACurrent
0713-5256Clindamycin HydrochlorideClindamycin HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
50090-3242Clindamycin HydrochlorideClindamycin HydrochlorideA-S Medication SolutionsANDACurrent
50090-3242Clindamycin HydrochlorideClindamycin HydrochlorideA-S Medication SolutionsANDACurrent
55154-5546Clindamycin HydrochlorideClindamycin HydrochlorideCardinal HealthANDACurrent
63187-381Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
63187-381Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
67296-1315Clindamycin HydrochlorideClindamycin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1315Clindamycin HydrochlorideClindamycin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1315Clindamycin HydrochlorideClindamycin HydrochlorideRedPharm Drug, Inc.ANDACurrent
68788-6401Clindamycin HydrochlorideClindamycin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6401Clindamycin HydrochlorideClindamycin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0238Clindamycin HydrochlorideClindamycin HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0429Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0454Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0454Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent