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Generated: December 12, 2017

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:1
Applicant:1
Ingredient:1
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 13985-610-02 1 BOTTLE, DROPPER in 1 CARTON (13985-610-02) > 2.5 mL in 1 BOTTLE, DROPPER
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 090887 ANDA Akorn, Inc. 17478-625 17478-625-12 1 BOTTLE, DROPPER in 1 CARTON (17478-625-12) > 2.5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

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


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