FDA.reportPublic FDA data

Application 063083

Type
ANDA
Sponsor
WATSON LABS

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
0179-0146Clindamycin HydrochlorideClindamycin HydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0179-0167Clindamycin HydrochlorideClindamycin HydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0591-2932Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2932Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2932Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2932Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5708Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5708Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5708Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5708Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5708Clindamycin HydrochlorideClindamycin HydrochlorideActavis Pharma, Inc.ANDACurrent
10544-154Clindamycin HydrochlorideClindamycin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
42291-389Clindamycin HydrochlorideClindamycin HydrochlorideAvKARE, Inc.ANDACurrent
49999-011Clindamycin HydrochlorideClindamycin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1798Clindamycin HydrochlorideClindamycin HydrochlorideA-S Medication SolutionsANDACurrent
50090-1951Clindamycin HydrochlorideClindamycin HydrochlorideA-S Medication SolutionsANDACurrent
50090-1951Clindamycin HydrochlorideClindamycin HydrochlorideA-S Medication SolutionsANDACurrent
53002-0621Clindamycin HydrochlorideClindamycin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-0621Clindamycin HydrochlorideClindamycin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-2320Clindamycin HydrochlorideClindamycin HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55154-6827Clindamycin HydrochlorideClindamycin HydrochlorideCardinal Health 107, LLCANDACurrent
55154-6827Clindamycin HydrochlorideClindamycin HydrochlorideCardinal HealthANDACurrent
55154-6827Clindamycin HydrochlorideClindamycin HydrochlorideCardinal HealthANDACurrent
55289-890Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-890Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-890Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-890Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-890Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-890Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-358Clindamycin HydrochlorideClindamycin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-570Clindamycin HydrochlorideClindamycin HydrochlorideSt. MaryANDACurrent
61919-310CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXANDACurrent
61919-310CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXANDACurrent
63187-556Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
63187-556Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
63187-556Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
63187-738Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
63187-738Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
63187-738Clindamycin HydrochlorideClindamycin HydrochlorideProficient Rx LPANDACurrent
63629-2817Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2817Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
63629-6328Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
63629-6328Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
63739-059Clindamycin HydrochlorideClindamycin HydrochlorideMcKesson CorporationANDACurrent
63739-059Clindamycin HydrochlorideClindamycin HydrochlorideMcKesson Corporation dba Sky PackagingANDACurrent
67046-084Clindamycin HydrochlorideClindamycin HydrochlorideContract Pharmacy Services-PAANDACurrent
67296-0073Clindamycin HydrochlorideClindamycin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1127Clindamycin HydrochlorideClindamycin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1127Clindamycin HydrochlorideClindamycin HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-3041Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals, IANDACurrent
68071-3041Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3041Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3175Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3175Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3175Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3175Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3207Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4027Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4027Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4027Clindamycin HydrochlorideClindamycin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6460Clindamycin HydrochlorideClindamycin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6460Clindamycin HydrochlorideClindamycin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7491Clindamycin HydrochlorideClindamycin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7491Clindamycin HydrochlorideClindamycin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70934-281Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-281Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-329Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-329Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-329Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0866Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0866Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0866Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1171Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1274Clindamycin HydrochlorideClindamycin HydrochlorideBryant Ranch PrepackANDACurrent