FDA.reportPublic FDA data

Application 085968

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL50MGNoNo
002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL25MGNoYes
003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL100MGNoNo
004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL10MGNoNo
005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL150MGNoNo
006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-0830Amitriptyline HydrochlorideAmitriptyline HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-1486Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1486Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1486Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1487Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1487Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1487Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1489Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1489Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1489Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1490Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1490Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1490Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1491Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1491Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0781-1491Amitriptyline HydrochlorideAmitriptyline HydrochlorideSandoz IncANDACurrent
0904-0201Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
0904-0201Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
0904-0202Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
0904-0202Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
0904-0202Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
0904-0202Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
0904-0202Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
0904-0202Amitriptyline HydrochlorideAmitriptyline HydrochlorideMajor PharmaceuticalsANDACurrent
10544-110Amitriptyline HydrochlorideAmitriptyline HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
16714-446Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-447Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-448Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-448Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-448Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-448Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-449Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-450Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
16714-451Amitriptyline HydrochlorideAmitriptyline HydrochlorideNorthstar RxLLCANDACurrent
21695-252Amitriptyline HydrochlorideAmitriptyline HydrochlorideRebel Distributors Corp.ANDACurrent
35356-742Amitriptyline HydrochlorideAmitriptyline HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
43063-836Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-836Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-836Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-836Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-836Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-836Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-164Amitriptyline HydrochlorideAmitriptyline HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-164Amitriptyline HydrochlorideAmitriptyline HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-5754Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
52959-514Amitriptyline HydrochlorideAmitriptyline HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
55154-7898Amitriptyline HydrochlorideAmitriptyline HydrochlorideCardinal HealthANDACurrent
63629-3597Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
64725-1488Amitriptyline HydrochlorideAmitriptyline HydrochlorideTYA PharmaceuticalsANDACurrent
67046-012Amitriptyline HydrochlorideAmitriptyline HydrochlorideContract Pharmacy Services-PAANDACurrent
68071-4238Amitriptyline HydrochlorideAmitriptyline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4238Amitriptyline HydrochlorideAmitriptyline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4238Amitriptyline HydrochlorideAmitriptyline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4238Amitriptyline HydrochlorideAmitriptyline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9015Amitriptyline HydrochlorideAmitriptyline HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69158-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEGLENVIEW PHARMA INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82721SUPPL 2025-07-01
82340SUPPL 2025-05-28
18511SUPPL2014-09-05