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

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020706

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NDA 020706 describes EMADINE, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. Additional details are available on the EMADINE profile page.

The generic ingredient in EMADINE is emedastine difumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the emedastine difumarate profile page.
Summary for 020706
Tradename:EMADINE
Applicant:Novartis Pharms Corp
Ingredient:emedastine difumarate
Patents:0
Pharmacology for NDA: 020706
Suppliers and Packaging for NDA: 020706
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMADINE emedastine difumarate SOLUTION/DROPS;OPHTHALMIC 020706 NDA Alcon Laboratories, Inc. 0065-0325 0065-0325-05 1 BOTTLE, PLASTIC in 1 CARTON (0065-0325-05) > 5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Dec 29, 1997TE:RLD:Yes

Expired US Patents for NDA 020706

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp EMADINE emedastine difumarate SOLUTION/DROPS;OPHTHALMIC 020706-001 Dec 29, 1997   Start Trial   Start Trial
Novartis Pharms Corp EMADINE emedastine difumarate SOLUTION/DROPS;OPHTHALMIC 020706-001 Dec 29, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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