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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
US Department of Justice
Cantor Fitzgerald
McKesson
Teva
Baxter
Citi
Queensland Health
Colorcon

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016949

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NDA 016949 describes LIMBITROL DS, which is a drug marketed by Heritage Pharms Inc and is included in one NDA. Additional details are available on the LIMBITROL DS profile page.

The generic ingredient in LIMBITROL DS is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.
Summary for 016949
Tradename:LIMBITROL DS
Applicant:Heritage Pharms Inc
Ingredient:amitriptyline hydrochloride; chlordiazepoxide
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 016949

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Heritage Pharms Inc LIMBITROL amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 016949-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Heritage Pharms Inc LIMBITROL DS amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 016949-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Chubb
Covington
Merck
Medtronic
Chinese Patent Office
Boehringer Ingelheim
QuintilesIMS
UBS

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