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Last Updated: December 8, 2019

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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 one supplier. 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. One supplier is 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
Pharmacology for NDA: 021258
Mechanism of ActionEstrogen Receptor Agonists
Physiological EffectInhibit Ovum Fertilization
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 50419-491-04 4 PATCH in 1 CARTON (50419-491-04) > 7 d in 1 PATCH
CLIMARA PRO estradiol; levonorgestrel FILM, EXTENDED RELEASE;TRANSDERMAL 021258 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-491 50419-491-73 1 PATCH in 1 CARTON (50419-491-73) > 7 d in 1 PATCH

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

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