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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200925

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NDA 200925 describes LATANOPROST, which is a drug marketed by Akorn, Amring Pharms, Apotex Inc, Bausch And Lomb, Dr Reddys Labs Ltd, Fdc Ltd, Mylan, and Sandoz Inc, and is included in eight NDAs. It is available from fourteen suppliers. Additional details are available on the LATANOPROST profile page.

The generic ingredient in LATANOPROST is latanoprost. There are nineteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.

Summary for 200925

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 200925

Ingredient-typeProstaglandins

Suppliers and Packaging for NDA: 200925

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 200925 ANDA American Regent, Inc. 0517-0830 0517-0830-01 1 BOTTLE, PLASTIC in 1 CARTON (0517-0830-01) > 2.5 mL in 1 BOTTLE, PLASTIC
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 200925 ANDA American Regent, Inc. 0517-0830 0517-0830-03 1 BOTTLE, PLASTIC in 1 CARTON (0517-0830-03) > 2.5 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.005%
Approval Date:Mar 22, 2011TE:ATRLD:No


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