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Serving leading biopharmaceutical companies globally:

McKinsey
Cantor Fitzgerald
Fish and Richardson
Cerilliant
Queensland Health
Johnson and Johnson
Mallinckrodt
Novartis
Merck
Covington

Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017920

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NDA 017920 describes TAGAMET, which is a drug marketed by Glaxosmithkline and Medtech Products and is included in six NDAs. Additional details are available on the TAGAMET profile page.

The generic ingredient in TAGAMET is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for 017920

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 14, 1983TE:RLD:No

Expired Orange Book Patents for NDA: 017920

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-004Dec 14, 1983► Subscribe► Subscribe
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-005Apr 30, 1986► Subscribe► Subscribe
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-005Apr 30, 1986► Subscribe► Subscribe
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-004Dec 14, 1983► Subscribe► Subscribe
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Glaxosmithkline
TAGAMET
cimetidine
TABLET;ORAL017920-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Dow
Harvard Business School
Covington
Cantor Fitzgerald
Baxter
Daiichi Sankyo
Queensland Health
Boehringer Ingelheim
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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