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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
US Department of Justice
Argus Health
Merck
Daiichi Sankyo
Cerilliant
Express Scripts
Colorcon
QuintilesIMS

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019462

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NDA 019462 describes PEPCID, which is a drug marketed by Merck, Salix Pharms, Valeant Pharms North, J And J Consumer Inc, and Merck Sharp Dohme, and is included in nine NDAs. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PEPCID profile page.

The generic ingredient in PEPCID is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and sixty-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for NDA: 019462

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 15, 1986TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 15, 1986TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019462

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-001Oct 15, 1986► Subscribe► Subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-002Oct 15, 1986► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Novartis
Healthtrust
Moodys
AstraZeneca
Julphar
QuintilesIMS
McKinsey
Chubb
Chinese Patent Office

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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