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PEPCID Drug Profile

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Pepcid 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 three suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in PEPCID is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and fifty-four 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 Tradename: PEPCID

Patents:4
Applicants:5
NDAs:9
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: PEPCID

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
PEPCID
famotidine
INJECTABLE;INJECTION019510-001Nov 4, 1986DISCNNo► subscribe► subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET, CHEWABLE;ORAL020801-002Dec 17, 2007OTCYes6,814,978*PED► subscribeY► subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-002Oct 15, 1986RXYes► subscribe► subscribe
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Expired Patents for Tradename: PEPCID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms
PEPCID
famotidine
FOR SUSPENSION;ORAL019527-001Feb 2, 19874,283,408*PED► subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-001Oct 15, 19864,283,408*PED► subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-002Oct 15, 19864,283,408*PED► subscribe
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Paragraph IV activity for: PEPCID

Drugname Dosage Strength RLD Submissiondate
calcium carbonate/ famotadine/ magnesium hydroxideChewable Tablets800 mg/ 10 mg/ 165 mg (OTC)Pepcid Complete11/1/2004
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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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