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Citi
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Harvard Business School
Daiichi Sankyo
US Department of Justice
Merck
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020375

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NDA 020375 describes CLIMARA, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the CLIMARA profile page.

The generic ingredient in CLIMARA is estradiol; levonorgestrel. There are seventy-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the estradiol; levonorgestrel profile page.
Summary for 020375
Tradename:CLIMARA
Applicant:Bayer Hlthcare
Ingredient:estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 020375
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 020375
Suppliers and Packaging for NDA: 020375
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375 NDA Alvogen, Inc. 47781-204 N 47781-204-04
CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375 NDA Alvogen, Inc. 47781-205 N 47781-205-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Dec 22, 1994TE:AB2RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Dec 22, 1994TE:AB2RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Mar 23, 1998TE:AB2RLD:Yes

Expired US Patents for NDA 020375

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-003 Mar 23, 1998 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-001 Dec 22, 1994 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-006 May 27, 2003 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-005 May 27, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Medtronic
Fish and Richardson
Teva
Moodys
US Army
Harvard Business School
McKesson
Boehringer Ingelheim

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