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Generated: June 26, 2019

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Details for New Drug Application (NDA): 019081

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NDA 019081 describes ESTRADERM, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the ESTRADERM profile page.

The generic ingredient in ESTRADERM is estradiol. There are seventy-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 019081
Tradename:ESTRADERM
Applicant:Novartis
Ingredient:estradiol
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019081

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Sep 10, 1986TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Sep 10, 1986TE:RLD:Yes

Expired US Patents for NDA 019081

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ESTRADERM estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 019081-003 Sep 10, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ESTRADERM estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 019081-003 Sep 10, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ESTRADERM estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 019081-002 Sep 10, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis ESTRADERM estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 019081-002 Sep 10, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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