FDA.reportPublic FDA data

Application 202446

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL50MGNoNo
004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL75MGNoNo
005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL100MGNoNo
006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7184AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-7185AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
16729-171AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-171AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-171AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-172AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-172AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-172AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-173AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-173AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-173AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-174AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-174AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-174AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-175AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-175AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-175AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-176AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-176AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
16729-176AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAccord Healthcare Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-863AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-432AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEMedsource PharmaceuticalsANDACurrent
45865-432AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEMedsource PharmaceuticalsANDACurrent
50090-2553AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2553AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2553AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2553AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2840AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2840AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3026AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3026AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3564AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3564AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3564AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3564AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3564AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-5015AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50436-2703AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-3710AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
51655-121AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENorthwind PharmaceuticalsANDACurrent
53002-3391AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
53002-4910AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
53002-4910AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
53217-269AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAidarex Pharmaceuticals LLCANDACurrent
53217-273AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAidarex Pharmaceuticals LLCANDACurrent
55700-600AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEQuality Care Products LLCANDACurrent
55700-600AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-600AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-600AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA QuaANDACurrent
55700-619AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-619AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-619AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-643AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-643AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-643AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-660AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-660AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-660AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-689AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-689AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-689AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-689AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-181AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-181AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-212AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-212AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-212AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-367AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-367AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
60760-367AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park PharmacyANDACurrent
61919-076AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-076AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-076AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEDirect_RxANDACurrent