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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020958

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NDA 020958 describes PEPCID COMPLETE, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PEPCID COMPLETE profile page.

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

Summary for 020958

Tradename:	PEPCID COMPLETE
Applicant:	J And J Consumer Inc
Ingredient:	calcium carbonate; famotidine; magnesium hydroxide
Patents:	2
Formulation / Manufacturing:	see details

Suppliers and Packaging for NDA: 020958

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958	NDA	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	16837-246	N	16837-246-50
PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958	NDA	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	16837-246	N	16837-246-25

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, CHEWABLE;ORAL			Strength	800MG;10MG;165MG
Approval Date:	Oct 16, 2000	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Mar 30, 2018	Product Flag?		Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Feb 26, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020958

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	➤ Sign Up	➤ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	➤ Sign Up	➤ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	➤ Sign Up	➤ Sign Up
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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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.