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Generated: March 22, 2018

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 thirteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 200925
Applicant:Amring Pharms
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200925
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 N 0517-0830-03
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 200925 ANDA American Regent, Inc. 0517-0830 N 0517-0830-01

Profile for product number 001

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

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Fish and Richardson

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