Details for New Drug Application (NDA): 213999
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The generic ingredient in AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 213999
Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
Applicant: | Mankind Pharma |
Ingredient: | amitriptyline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213999
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 213999 | ANDA | Northwind Pharmaceuticals, LLC | 51655-084 | 51655-084-26 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-26) |
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 213999 | ANDA | Northwind Pharmaceuticals, LLC | 51655-084 | 51655-084-52 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-52) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Feb 19, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Feb 19, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Feb 19, 2021 | TE: | AB | RLD: | No |
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