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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090397

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NDA 090397 describes IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Strides Pharma and Bionpharma Inc and is included in two NDAs. It is available from fourteen suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There are twenty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.

Summary for NDA: 090397

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090397

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride; ibuprofen
CAPSULE;ORAL 090397 ANDA Walgreens 0363-0665 0363-0665-20 1 BOTTLE, PLASTIC in 1 BOX (0363-0665-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride; ibuprofen
CAPSULE;ORAL 090397 ANDA Walgreens 0363-0665 0363-0665-40 1 BOTTLE, PLASTIC in 1 BOX (0363-0665-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Nov 22, 2010TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Deloitte
Harvard Business School
Fish and Richardson
AstraZeneca
UBS
Cipla
Julphar
Argus Health
US Army

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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