FDA.reportPublic FDA data

Application 207402

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoNo
003CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42571-250CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-250CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-250CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-250CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-250CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-250CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-251CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-251CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-251CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-251CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-251CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-251CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-252CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-252CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-252CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-252CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-252CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
42571-252CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideMicro Labs LimitedANDACurrent
50090-4575CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideA-S Medication SolutionsANDACurrent
50090-4575CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideA-S Medication SolutionsANDACurrent
50090-4661CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideA-S Medication SolutionsANDACurrent
50090-4661CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideA-S Medication SolutionsANDACurrent
50268-185CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideAvPAKANDACurrent
50268-185CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideAvPAKANDACurrent
53002-0622CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-2321CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-761CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideQuality Care Products, LLCANDACurrent
55700-761CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideQuality Care Products, LLCANDACurrent
55700-761CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideQuality Care Products, LLCANDACurrent
60760-427CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-487CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-487CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-487CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
67296-1702CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1702CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1702CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1749CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1749CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1749CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-2286Clindamycin hydrochlorideClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2286Clindamycin hydrochlorideClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2346CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2372CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5174CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5174CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5189CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5189CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5189CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5189CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5189CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7753CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7753CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7753CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2153CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2153CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2153CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2153CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2153CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2153CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2153CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-626CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-444CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideProficient Rx LPANDACurrent
71205-444CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideProficient Rx LPANDACurrent
71205-444CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideProficient Rx LPANDACurrent
71205-444CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideProficient Rx LPANDACurrent
71205-444CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideProficient Rx LPANDACurrent
71335-1412CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideBryant Ranch PrepackANDACurrent
71335-1412CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideBryant Ranch PrepackANDACurrent
71335-1412CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideBryant Ranch PrepackANDACurrent
71335-1412CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideBryant Ranch PrepackANDACurrent
71335-1489CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideBryant Ranch PrepackANDACurrent
71335-1489CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideBryant Ranch PrepackANDACurrent
71335-1489CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochlorideBryant Ranch PrepackANDACurrent
72189-189CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXANDACurrent
72789-167CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-167CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-167CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-167CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-167CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-167CLINDAMYCIN HYDROCHLORIDEClindamycin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent