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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Department of Justice
Daiichi Sankyo
Express Scripts
Cipla
UBS
Federal Trade Commission
Teva
McKinsey

Generated: August 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012703

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NDA 012703 describes ELAVIL, which is a drug marketed by Astrazeneca and is included in two NDAs. Additional details are available on the ELAVIL profile page.

The generic ingredient in ELAVIL is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 012703
Tradename:ELAVIL
Applicant:Astrazeneca
Ingredient:amitriptyline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 012703

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 012703

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-007 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-004 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-003 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca ELAVIL amitriptyline hydrochloride TABLET;ORAL 012703-005 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Boehringer Ingelheim
Farmers Insurance
UBS
Daiichi Sankyo
Federal Trade Commission
Fuji
Covington
Argus Health

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