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Moodys
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Dow
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Fuji
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McKesson
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Generated: February 22, 2018

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 Bionpharma Inc and Strides Pharma 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 090397
Tradename:IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:Bionpharma Inc
Ingredient:diphenhydramine hydrochloride; ibuprofen
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 N 0363-0665-40
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 090397 ANDA Walgreens 0363-0665 N 0363-0665-20

Profile 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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