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Details for New Drug Application (NDA): 022014

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NDA 022014 describes EVAMIST, which is a drug marketed by Elan Pharma Intl Ltd and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug. Additional details are available on the EVAMIST profile page.

The generic ingredient in EVAMIST is estradiol. There are seventy-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 022014

Tradename:
EVAMIST
Applicant:
Elan Pharma Intl Ltd
Ingredient:
estradiol
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 022014

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 022014

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVAMIST
estradiol
SPRAY;TRANSDERMAL 022014 NDA Paddock Laboratories, LLC 0574-2067 0574-2067-00 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)
EVAMIST
estradiol
SPRAY;TRANSDERMAL 022014 NDA Paddock Laboratories, LLC 0574-2067 0574-2067-27 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TRANSDERMALStrength1.53MG/SPRAY
Approval Date:Jul 27, 2007TE:RLD:Yes
Patent:6,978,945Patent Expiration:Jul 31, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:6,299,900Patent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN
Patent:6,818,226Patent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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