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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 NDA: 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

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 47781-204-04 4 PATCH in 1 CARTON (47781-204-04) > 7 d in 1 PATCH
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 020375 NDA Alvogen, Inc. 47781-205 47781-205-04 4 PATCH in 1 CARTON (47781-205-04) > 7 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Dec 22, 1994TE:AB2RLD:No

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Mar 23, 1998TE:AB2RLD:No

Expired Orange Book Patents for NDA: 020375

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-004Mar 5, 19995,223,261► subscribe
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-003Mar 23, 19985,223,261► subscribe
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-006May 27, 20035,223,261► subscribe
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