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Generated: May 29, 2017

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Details for New Drug Application (NDA): 201786

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NDA 201786 describes LATANOPROST, which is a drug marketed by Bausch And Lomb, Amring Pharms, Fdc Ltd, Sandoz Inc, Dr Reddys Labs Ltd, Mylan, Akorn, and Apotex Inc, and is included in eight NDAs. It is available from twelve 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. Fifteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.

Summary for NDA: 201786

Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201786


Suppliers and Packaging for NDA: 201786

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;OPHTHALMIC 201786 ANDA Mylan Pharmaceuticals Inc. 0378-9645 0378-9645-32 1 BOTTLE in 1 CARTON (0378-9645-32) > 2.5 mL in 1 BOTTLE
SOLUTION/DROPS;OPHTHALMIC 201786 ANDA Mylan Pharmaceuticals Inc. 0378-9645 0378-9645-53 3 BOTTLE in 1 CARTON (0378-9645-53) > 2.5 mL in 1 BOTTLE

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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