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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020869

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NDA 020869 describes COSOPT, which is a drug marketed by Oak Pharms Inc and is included in two NDAs. It is available from three suppliers. Additional details are available on the COSOPT profile page.

The generic ingredient in COSOPT is dorzolamide hydrochloride; timolol maleate. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for NDA: 020869

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020869

Suppliers and Packaging for NDA: 020869

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COSOPT
dorzolamide hydrochloride; timolol maleate
SOLUTION/DROPS;OPHTHALMIC 020869 NDA Akorn 17478-605 17478-605-10 1 BOTTLE, DROPPER in 1 CARTON (17478-605-10) > 10 mL in 1 BOTTLE, DROPPER
COSOPT
dorzolamide hydrochloride; timolol maleate
SOLUTION/DROPS;OPHTHALMIC 020869 NDA Physicians Total Care, Inc. 54868-4279 54868-4279-0 1 BOTTLE, DROPPER in 1 CARTON (54868-4279-0) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE;EQ 0.5% BASE
Approval Date:Apr 7, 1998TE:ATRLD:Yes

Expired Orange Book Patents for NDA: 020869

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
COSOPT
dorzolamide hydrochloride; timolol maleate
SOLUTION/DROPS;OPHTHALMIC020869-001Apr 7, 19984,619,939*PED► Subscribe
Oak Pharms Inc
COSOPT
dorzolamide hydrochloride; timolol maleate
SOLUTION/DROPS;OPHTHALMIC020869-001Apr 7, 19986,248,735► Subscribe
Oak Pharms Inc
COSOPT
dorzolamide hydrochloride; timolol maleate
SOLUTION/DROPS;OPHTHALMIC020869-001Apr 7, 19986,316,443► Subscribe
Oak Pharms Inc
COSOPT
dorzolamide hydrochloride; timolol maleate
SOLUTION/DROPS;OPHTHALMIC020869-001Apr 7, 19984,797,413*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Accenture
McKinsey
Queensland Health
Fish and Richardson
AstraZeneca
Moodys
Merck
Federal Trade Commission
Baxter
Express Scripts

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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