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Details for New Drug Application (NDA): 020802

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NDA 020802 describes EXCEDRIN (MIGRAINE), which is a drug marketed by Glaxosmithkline Cons and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug. Additional details are available on the EXCEDRIN (MIGRAINE) profile page.

The generic ingredient in EXCEDRIN (MIGRAINE) is acetaminophen; aspirin; caffeine. There are sixty-five drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; aspirin; caffeine profile page.

Summary for NDA: 020802

Tradename:
EXCEDRIN (MIGRAINE)
Applicant:
Glaxosmithkline Cons
Ingredient:
acetaminophen; aspirin; caffeine
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020802

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXCEDRIN (MIGRAINE)
acetaminophen; aspirin; caffeine
TABLET;ORAL 020802 NDA Novartis Consumer Health, Inc 0067-2035 0067-2035-16 2 BOTTLE in 1 CARTON (0067-2035-16) > 160 TABLET, COATED in 1 BOTTLE
EXCEDRIN (MIGRAINE)
acetaminophen; aspirin; caffeine
TABLET;ORAL 020802 NDA Novartis Consumer Health, Inc 0067-2035 0067-2035-20 1 BOTTLE in 1 CARTON (0067-2035-20) > 20 TABLET, COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength250MG;250MG;65MG
Approval Date:Jan 14, 1998TE:RLD:Yes
Patent:5,972,916Patent Expiration:Jul 14, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING MIGRAINE PAIN AND ONE OR MORE OF A CLUSTER OF SYMPTOMS CHARACTERISTIC OF A MIGRAINE ATTACK SYMPTOMS BEING SELECTED FROM PHOTOPHOBIA, PHONOPHOBIA NAUSEA AND FUNCTIONAL DISABILITY

Expired Orange Book Patents for NDA: 020802

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
EXCEDRIN (MIGRAINE)
acetaminophen; aspirin; caffeine
TABLET;ORAL020802-001Jan 14, 19984,943,565► 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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