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Details for New Drug Application (NDA): 020706

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NDA 020706 describes EMADINE, which is a drug marketed by Alcon 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 NDA: 020706

Tradename:
EMADINE
Applicant:
Alcon
Ingredient:
emedastine difumarate
Patents:0
Therapeutic Class:Ophthalmic Agents

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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020706

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon
EMADINE
emedastine difumarate
SOLUTION/DROPS;OPHTHALMIC020706-001Dec 29, 19974,430,343► subscribe
Alcon
EMADINE
emedastine difumarate
SOLUTION/DROPS;OPHTHALMIC020706-001Dec 29, 19975,441,958► subscribe
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