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Details for New Drug Application (NDA): 206581

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NDA 206581 describes IBUPROFEN SODIUM, which is a drug marketed by Perrigo R And D and is included in one NDA. It is available from four suppliers. Additional details are available on the IBUPROFEN SODIUM profile page.

The generic ingredient in IBUPROFEN SODIUM is ibuprofen sodium. There are sixty-three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.

Summary for NDA: 206581

Tradename:
IBUPROFEN SODIUM
Applicant:
Perrigo R And D
Ingredient:
ibuprofen sodium
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206581

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN SODIUM
ibuprofen sodium
TABLET;ORAL 206581 ANDA Walgreen Company 0363-0909 0363-0909-27 1 BOTTLE in 1 CARTON (0363-0909-27) > 80 TABLET, FILM COATED in 1 BOTTLE
IBUPROFEN SODIUM
ibuprofen sodium
TABLET;ORAL 206581 ANDA Walgreen Company 0363-0909 0363-0909-49 1 BOTTLE in 1 CARTON (0363-0909-49) > 40 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Aug 3, 2015TE:RLD:No


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