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Dow
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US Department of Justice
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090887

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NDA 090887 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 090887
Tradename:LATANOPROST
Applicant:Akorn
Ingredient:latanoprost
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090887
Ingredient-typeProstaglandins
Suppliers and Packaging for NDA: 090887
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 090887 ANDA MWI 13985-610 N 13985-610-02
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 090887 ANDA Akorn, Inc. 17478-625 N 17478-625-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.005%
Approval Date:Jul 19, 2011TE:ATRLD:No

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