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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 three suppliers. 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 NDA: 019404

Tradename:
OCUFEN
Applicant:
Allergan
Ingredient:
flurbiprofen sodium
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019404

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 Allergan, Inc. 11980-801 11980-801-03 1 BOTTLE, DROPPER in 1 CARTON (11980-801-03) > 2.5 mL in 1 BOTTLE, DROPPER
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019404

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
OCUFEN
flurbiprofen sodium
SOLUTION/DROPS;OPHTHALMIC019404-001Dec 31, 19863,755,427► subscribe
Allergan
OCUFEN
flurbiprofen sodium
SOLUTION/DROPS;OPHTHALMIC019404-001Dec 31, 19863,793,457► subscribe
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