FDA.reportPublic FDA data

Application 214548

Type
ANDA
Sponsor
UNICHEM

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
29300-419Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-419Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-420Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-420Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-421Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-421Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-422Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-422Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-423Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-423Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-424Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-424Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-6179Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-6313Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-6315Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
60760-556Amitriptyline HydrochlorideAmitriptyline HydrochlorideST. MARY'S MEDICAL PARK PHARMACYANDACurrent
68071-2796Amitriptyline HydrochlorideAmitriptyline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2843Amitriptyline HydrochlorideAmitriptyline HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8218Amitriptyline HydrochlorideAmitriptyline HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent