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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 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 NDA: 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 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 Physicians Total Care, Inc. 54868-5570 54868-5570-0 4 PATCH in 1 CARTON (54868-5570-0)

Summary 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 Orange Book 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;TRANSDERMAL021258-001Nov 21, 20035,252,334► subscribe
Bayer Hlthcare
CLIMARA PRO
estradiol; levonorgestrel
FILM, EXTENDED RELEASE;TRANSDERMAL021258-001Nov 21, 20035,770,219► subscribe
Bayer Hlthcare
CLIMARA PRO
estradiol; levonorgestrel
FILM, EXTENDED RELEASE;TRANSDERMAL021258-001Nov 21, 20035,676,968► subscribe
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