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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021871

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NDA 021871 describes LOESTRIN 24 FE, which is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. Additional details are available on the LOESTRIN 24 FE profile page.

The generic ingredient in LOESTRIN 24 FE 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 021871
Tradename:LOESTRIN 24 FE
Ingredient:ethinyl estradiol; norethindrone acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021871
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOESTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 021871 NDA Actavis Pharma, Inc. 52544-167 N 52544-167-31
LOESTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 021871 NDA Physicians Total Care, Inc. 54868-6100 E 54868-6100-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 17, 2006TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Cantor Fitzgerald
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