FDA.reportPublic FDA data

Application 040218

Type
ANDA
Sponsor
VINTAGE PHARMS

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
0463-6351Amitriptyline HydrochlorideAmitriptyline HydrochlorideC.O. Truxton, Inc.ANDACurrent
0463-6352Amitriptyline HydrochlorideAmitriptyline HydrochlorideC.O. Truxton, Inc.ANDACurrent
0463-6354Amitriptyline HydrochlorideAmitriptyline HydrochlorideC.O. Truxton, Inc.ANDACurrent
0603-2212Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2212Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2212Amitriptyline HydrochlorideAmitriptyline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-2213Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2213Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2213Amitriptyline HydrochlorideAmitriptyline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-2214Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2214Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2214Amitriptyline HydrochlorideAmitriptyline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-2215Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2215Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2215Amitriptyline HydrochlorideAmitriptyline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-2216Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2216Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2216Amitriptyline HydrochlorideAmitriptyline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-2217Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2217Amitriptyline HydrochlorideAmitriptyline HydrochloridePar PharmaceuticalANDACurrent
0603-2217Amitriptyline HydrochlorideAmitriptyline HydrochloridePar Pharmaceutical, Inc.ANDACurrent
33261-007Amitriptyline HydrochlorideAmitriptyline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-358Amitriptyline HydrochlorideAmitriptyline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-363Amitriptyline HydrochlorideAmitriptyline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-459Amitriptyline HydrochlorideAmitriptyline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-626Amitriptyline HydrochlorideAmitriptyline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-944Amitriptyline HydrochlorideAmitriptyline HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
35356-712Amitriptyline HydrochlorideAmitriptyline HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-759Amitriptyline HydrochlorideAmitriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-193Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-336Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-228Amitriptyline HydrochlorideAmitriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0030Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0031Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0264Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0264Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0264Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0264Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50090-0333Amitriptyline HydrochlorideAmitriptyline HydrochlorideA-S Medication SolutionsANDACurrent
50436-3073Amitriptyline HydrochlorideAmitriptyline HydrochlorideUnit Dose ServicesANDACurrent
55289-016Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-124Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-124Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-124Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-124Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-730Amitriptyline HydrochlorideAmitriptyline HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-241Amitriptyline HydrochlorideAmitriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-391Amitriptyline HydrochlorideAmitriptyline HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-011AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-240AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEDIRECT RXANDACurrent
63187-155Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63187-155Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63187-156Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63187-156Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63187-229Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63187-229Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63187-260Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63187-260Amitriptyline HydrochlorideAmitriptyline HydrochlorideProficient Rx LPANDACurrent
63629-1368Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-1368Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2115Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2115Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2116Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2116Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2117Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2117Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2118Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2118Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2119Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2119Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2120Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2120Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2121Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2121Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2122Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2122Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2123Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-2123Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-6630Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8987Amitriptyline HydrochlorideAmitriptyline HydrochlorideBryant Ranch PrepackANDACurrent