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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Generated: August 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090449

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NDA 090449 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 eight 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. Nine suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.
Summary for 090449
Tradename:BIMATOPROST
Applicant:Apotex Inc
Ingredient:bimatoprost
Patents:0
Pharmacology for NDA: 090449
Ingredient-typeProstaglandins
Medical Subject Heading (MeSH) Categories for 090449
Suppliers and Packaging for NDA: 090449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 090449 ANDA Apotex Corp. 60505-0583 60505-0583-1 1 BOTTLE, DROPPER in 1 CARTON (60505-0583-1) > 5 mL in 1 BOTTLE, DROPPER
BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 090449 ANDA Apotex Corp. 60505-0583 60505-0583-4 1 BOTTLE, DROPPER in 1 CARTON (60505-0583-4) > 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

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

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