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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Argus Health
Chubb
Cipla
Johnson and Johnson
Dow
Julphar
Queensland Health
Express Scripts

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021258

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NDA 021258 describes CLIMARA PRO, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. Additional details are available on the CLIMARA PRO profile page.

The generic ingredient in CLIMARA PRO 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 021258
Tradename:CLIMARA PRO
Applicant:Bayer Hlthcare
Ingredient:estradiol; levonorgestrel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021258
Suppliers and Packaging for NDA: 021258
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLIMARA PRO estradiol; levonorgestrel FILM, EXTENDED RELEASE;TRANSDERMAL 021258 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-491 N 50419-491-04
CLIMARA PRO estradiol; levonorgestrel FILM, EXTENDED RELEASE;TRANSDERMAL 021258 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-491 N 50419-491-73

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.045MG/24HR;0.015MG/24HR
Approval Date:Nov 21, 2003TE:RLD:Yes

Expired US Patents for NDA 021258

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CLIMARA PRO estradiol; levonorgestrel FILM, EXTENDED RELEASE;TRANSDERMAL 021258-001 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CLIMARA PRO estradiol; levonorgestrel FILM, EXTENDED RELEASE;TRANSDERMAL 021258-001 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CLIMARA PRO estradiol; levonorgestrel FILM, EXTENDED RELEASE;TRANSDERMAL 021258-001 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CLIMARA PRO estradiol; levonorgestrel FILM, EXTENDED RELEASE;TRANSDERMAL 021258-001 Nov 21, 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:

Colorcon
Julphar
Harvard Business School
Cerilliant
Queensland Health
Federal Trade Commission
Dow
Farmers Insurance
UBS

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