Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203991

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NDA 203991 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 203991
Tradename:BIMATOPROST
Applicant:Lupin Ltd
Ingredient:bimatoprost
Patents:0
Pharmacology for NDA: 203991
Medical Subject Heading (MeSH) Categories for 203991
Suppliers and Packaging for NDA: 203991
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 203991 ANDA Lupin Pharmaceuticals, Inc. 68180-429 68180-429-01 1 BOTTLE, DROPPER in 1 CARTON (68180-429-01) > 2.5 mL in 1 BOTTLE, DROPPER
BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 203991 ANDA Lupin Pharmaceuticals, Inc. 68180-429 68180-429-02 1 BOTTLE, DROPPER in 1 CARTON (68180-429-02) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.03%
Approval Date:Feb 20, 2015TE:ATRLD:No

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