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Generated: December 12, 2018

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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 one supplier. 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 020869
Tradename:COSOPT
Applicant:Oak Pharms Inc
Ingredient:dorzolamide hydrochloride; timolol maleate
Patents:0
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

Profile 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 US 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;OPHTHALMIC 020869-001 Apr 7, 1998 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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