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Generated: May 25, 2017

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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-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for NDA: 021065

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 Warner Chilcott (US), LLC 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

Summary for product number 001

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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 021065

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 20055,208,225► Subscribe
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-002Oct 15, 19995,208,225► Subscribe
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