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Details for New Drug Application (NDA): 200888

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NDA 200888 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: 200888

Tradename:
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:
Strides Pharma
Ingredient:
diphenhydramine hydrochloride; ibuprofen
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 200888

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride; ibuprofen
CAPSULE;ORAL 200888 ANDA WALGREEN CO. 0363-0611 0363-0611-21 2 BLISTER PACK in 1 CARTON (0363-0611-21) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride; ibuprofen
CAPSULE;ORAL 200888 ANDA L.N.K. International, Inc. 50844-611 50844-611-19 1 BLISTER PACK in 1 CARTON (50844-611-19) > 8 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:Mar 5, 2012TE:RLD:No


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