FDA.report

Application 202825

Type
ANDA
Sponsor
ACCORD HLTHCARE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 25MG BASENoNo
002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-215SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-215SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-215SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-215SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-216SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-216SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-216SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-216SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-217SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-217SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-217SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
16729-217SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.ANDACurrent
42708-092SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQPharma IncANDACurrent
42708-092Sertraline HydrochlorideSertraline HydrochlorideQPharma IncANDACurrent
42708-092SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQPharma IncANDACurrent
43063-855SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, InANDACurrent
43063-855SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-855SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-855SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-855SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3203SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3203SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3203SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3203SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3945SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3945SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3945SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3945SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3945SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3947SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3947SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3947SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3947SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50436-0215SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-0215SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-0216SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-0216SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-0217SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-0217SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
53002-4215SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
55700-910SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-910SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-948SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-948SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-948SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-977SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
60760-737SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-737SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-737SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-738SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-738SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-738SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
61919-345Sertraline HydrochlorideSertraline HydrochlorideDirect RxANDACurrent
61919-345SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-345Sertraline HydrochlorideSertraline HydrochlorideDirect_RxANDACurrent
61919-345Sertraline HydrochlorideSertraline HydrochlorideDirect_RxANDACurrent
61919-345Sertraline HydrochlorideSertraline HydrochlorideDirect RxANDACurrent
61919-345Sertraline HydrochlorideSertraline HydrochlorideDirect_RxANDACurrent
61919-345Sertraline HydrochlorideSertraline HydrochlorideDirect RxANDACurrent
68071-2496SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-3309SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.ANDACurrent
68071-3309SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.ANDACurrent
68071-3379SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.ANDACurrent
68071-4029SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4029SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4029SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4750SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4750SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68788-7001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7035SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7035SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7035SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7928SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7928SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-8109SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-8109SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-8210SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
70518-1615SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1615SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent