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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091449

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NDA 091449 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 ten 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. Twelve suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 091449
Tradename:LATANOPROST
Applicant:Sandoz Inc
Ingredient:latanoprost
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091449
Ingredient-typeProstaglandins
Suppliers and Packaging for NDA: 091449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 091449 ANDA Sandoz Inc 61314-547 N 61314-547-01
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 091449 ANDA Sandoz Inc 61314-547 N 61314-547-03

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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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Accenture
US Army
Dow
Covington
QuintilesIMS
Mallinckrodt
Cerilliant
Chinese Patent Office

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