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Details for New Drug Application (NDA): 200925

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

The generic ingredient in LATANOPROST is latanoprost. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the latanoprost profile page.

Summary for NDA: 200925

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 200925


Suppliers and Packaging for NDA: 200925

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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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