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Details for New Drug Application (NDA): 021393

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NDA 021393 describes ADVIL PM, which is a drug marketed by Pfizer and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug. Additional details are available on the ADVIL PM profile page.

The generic ingredient in ADVIL PM is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

Summary for NDA: 021393

Tradename:
ADVIL PM
Applicant:
Pfizer
Ingredient:
diphenhydramine hydrochloride; ibuprofen
Patents:2
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021393

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL PM
diphenhydramine hydrochloride; ibuprofen
CAPSULE;ORAL 021393 NDA Pfizer Consumer Healthcare 0573-0167 0573-0167-10 16 BLISTER PACK in 1 CARTON (0573-0167-10) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
ADVIL PM
diphenhydramine hydrochloride; ibuprofen
CAPSULE;ORAL 021393 NDA Pfizer Consumer Healthcare 0573-0167 0573-0167-18 24 BLISTER PACK in 1 CARTON (0573-0167-18) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Dec 21, 2005TE:RLD:Yes
Patent:9,155,718Patent Expiration:Jan 17, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:8,883,849Patent Expiration:Jan 17, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FONNULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT


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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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