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Details for New Drug Application (NDA): 020249

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NDA 020249 describes PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. Additional details are available on the PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER profile page.

The generic ingredient in PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER is famotidine. There are eighteen drug master file entries for this compound. One hundred and twenty suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the famotidine profile page.

Summary for NDA: 020249

Tradename:
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
Applicant:
Merck Sharp Dohme
Ingredient:
famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Feb 18, 1994TE:RLD:No

Expired Orange Book Patents for NDA: 020249

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
famotidine
INJECTABLE;INJECTION020249-001Feb 18, 19944,283,408*PED► subscribe
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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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