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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210263

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NDA 210263 describes BIMATOPROST, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Hi-tech Pharma Co, Lupin Ltd, Sandoz Inc, Somerset Theraps Llc, and Hi Tech, and is included in ten 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 210263
Tradename:BIMATOPROST
Applicant:Alembic Pharms Ltd
Ingredient:bimatoprost
Patents:0
Pharmacology for NDA: 210263
Medical Subject Heading (MeSH) Categories for 210263
Suppliers and Packaging for NDA: 210263
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 210263 ANDA Alembic Pharmaceuticals Inc. 62332-507 62332-507-05 1 BOTTLE in 1 CARTON (62332-507-05) > 5 mL in 1 BOTTLE
BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 210263 ANDA Alembic Pharmaceuticals Inc. 62332-507 62332-507-25 1 BOTTLE in 1 CARTON (62332-507-25) > 2.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.03%
Approval Date:Apr 12, 2019TE:ATRLD:No

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