Details for New Drug Application (NDA): 020958

✉ Email this page to a colleague

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 five suppliers. 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 eighty-two drug master file entries for this compound. Twenty-three 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:	0

Pharmacology for NDA: 020958

Mechanism of Action	Histamine H2 Receptor Antagonists

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	Kenvue Brands LLC	16837-246	16837-246-25	25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25)
PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958	NDA	Kenvue Brands LLC	16837-246	16837-246-50	50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)

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

Expired US Patents for NDA 020958

Subscribe to access the full database, or Sign Up
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.