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Generated: June 25, 2017

DrugPatentWatch Database Preview

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. Four suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.

Summary for NDA: 019404

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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

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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Serving 500+ biopharmaceutical companies globally:

Dow
Moodys
US Department of Justice
Cantor Fitzgerald
QuintilesIMS
Express Scripts
Citi
Novartis
Accenture
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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