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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
UBS
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Accenture
Citi
Cerilliant
Novartis
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021065

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NDA 021065 describes FEMHRT, which is a drug marketed by Apil and is included in one NDA. It is available from three suppliers. Additional details are available on the FEMHRT profile page.

The generic ingredient in FEMHRT is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 021065
Tradename:FEMHRT
Applicant:Apil
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021065
Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 021065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065 NDA Allergan, Inc. 0430-0145 0430-0145-14 5 POUCH in 1 CARTON (0430-0145-14) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK
FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065 NDA Actavis Pharma, Inc. 52544-236 52544-236-31 3 POUCH in 1 CARTON (52544-236-31) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.0025MG;0.5MG
Approval Date:Jan 14, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 15, 1999TE:RLD:Yes

Expired US Patents for NDA 021065

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 ➤ Subscribe ➤ Subscribe
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-002 Oct 15, 1999 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
Fuji
Cerilliant
Merck
Baxter
Julphar
Federal Trade Commission
Cipla

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