DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 086009
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
The generic ingredient in AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 086009
Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
Applicant: | Mylan |
Ingredient: | amitriptyline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 086009
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 086009 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2610 | 0378-2610-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2610-01) |
AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 086009 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2610 | 0378-2610-10 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2610-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
Complete Access Available with Subscription