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Generated: November 20, 2018

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Details for New Drug Application (NDA): 020408

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NDA 020408 describes TRUSOPT, which is a drug marketed by Merck and is included in one NDA. It is available from one supplier. Additional details are available on the TRUSOPT profile page.

The generic ingredient in TRUSOPT is dorzolamide hydrochloride. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride profile page.
Summary for 020408
Tradename:TRUSOPT
Applicant:Merck
Ingredient:dorzolamide hydrochloride
Patents:0
Pharmacology for NDA: 020408
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 020408
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRUSOPT dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 020408 NDA Merck Sharp & Dohme Corp. 0006-3519 0006-3519-36 1 BOTTLE, DROPPER in 1 CARTON (0006-3519-36) > 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Dec 9, 1994TE:ATRLD:Yes

Expired US Patents for NDA 020408

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck TRUSOPT dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 020408-001 Dec 9, 1994 ➤ Sign Up ➤ Sign Up
Merck TRUSOPT dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 020408-001 Dec 9, 1994 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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