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Generated: May 26, 2017

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Details for New Drug Application (NDA): 202719

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NDA 202719 describes BIMATOPROST, which is a drug marketed by Sandoz Inc, Apotex Inc, and Lupin Ltd, and is included in five NDAs. It is available from three suppliers. Additional details are available on the BIMATOPROST profile page.

The generic ingredient in BIMATOPROST is bimatoprost. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

Summary for NDA: 202719

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 202719


Suppliers and Packaging for NDA: 202719

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;TOPICAL 202719 ANDA Sandoz Inc 0781-6206 0781-6206-75 5 mL in 1 BOTTLE (0781-6206-75)
SOLUTION/DROPS;TOPICAL 202719 ANDA Sandoz Inc 0781-6206 0781-6206-93 3 mL in 1 BOTTLE (0781-6206-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;TOPICALStrength0.03%
Approval Date:Apr 19, 2016TE:ATRLD:No

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