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Generated: November 17, 2018

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Details for New Drug Application (NDA): 019404

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NDA 019404 describes OCUFEN, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. Additional details are available on the OCUFEN profile page.

The generic ingredient in OCUFEN is flurbiprofen sodium. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.
Summary for 019404
Tradename:OCUFEN
Applicant:Allergan
Ingredient:flurbiprofen sodium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019404
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCUFEN flurbiprofen sodium SOLUTION/DROPS;OPHTHALMIC 019404 NDA AUTHORIZED GENERIC Rebel Distributors Corp 42254-023 42254-023-25 1 BOTTLE, DROPPER in 1 CARTON (42254-023-25) > 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.03%
Approval Date:Dec 31, 1986TE:ATRLD:Yes

Expired US Patents for NDA 019404

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan OCUFEN flurbiprofen sodium SOLUTION/DROPS;OPHTHALMIC 019404-001 Dec 31, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan OCUFEN flurbiprofen sodium SOLUTION/DROPS;OPHTHALMIC 019404-001 Dec 31, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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