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Details for New Drug Application (NDA): 020655

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NDA 020655 describes ALORA, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ALORA profile page.

The generic ingredient in ALORA 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: 020655

Tradename:
ALORA
Applicant:
Allergan Sales Llc
Ingredient:
estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020655

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 020655

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 020655 NDA Actavis Pharma, Inc. 52544-471 52544-471-08 8 POUCH in 1 BOX (52544-471-08) > 1 PATCH in 1 POUCH > 3.5 d in 1 PATCH
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 020655 NDA Actavis Pharma, Inc. 52544-472 52544-472-08 8 POUCH in 1 BOX (52544-472-08) > 1 PATCH in 1 POUCH > 3.5 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Dec 20, 1996TE:BXRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Dec 20, 1996TE:BXRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Dec 20, 1996TE:BXRLD:No

Expired Orange Book Patents for NDA: 020655

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-002Dec 20, 19965,164,190► subscribe
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-001Dec 20, 19965,212,199► subscribe
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-001Dec 20, 19965,227,169► subscribe
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