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 Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit 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:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.045MG/24HR;0.015MG/24HR
Approval Date:	Nov 21, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021258

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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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