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Last Updated: April 16, 2024

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. One supplier is 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020375

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 020375

Estrogens

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 AUTHORIZED GENERIC	Sandoz Inc	0781-7104	0781-7104-54	4 PATCH in 1 CARTON (0781-7104-54) / 7 d in 1 PATCH (0781-7104-58)
CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7119	0781-7119-54	4 PATCH in 1 CARTON (0781-7119-54) / 7 d in 1 PATCH (0781-7119-58)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.05MG/24HR
Approval Date:	Dec 22, 1994	TE:	AB2	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.1MG/24HR
Approval Date:	Dec 22, 1994	TE:	AB2	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.075MG/24HR
Approval Date:	Mar 23, 1998	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 020375

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

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