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Generated: July 15, 2019

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Details for New Drug Application (NDA): 203051

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NDA 203051 describes BIMATOPROST, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Hi-tech Pharma Co, Lupin Ltd, Sandoz Inc, and Hi Tech, and is included in nine NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.
Summary for 203051
Applicant:Hi Tech
Pharmacology for NDA: 203051
Medical Subject Heading (MeSH) Categories for 203051
Suppliers and Packaging for NDA: 203051
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIMATOPROST bimatoprost SOLUTION/DROPS;TOPICAL 203051 ANDA Hi-Tech Pharmacal Co., Inc. 50383-912 50383-912-03 1 BOTTLE in 1 KIT (50383-912-03) > 3 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;TOPICALStrength0.03%
Approval Date:Oct 9, 2018TE:ATRLD:No

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