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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Boehringer Ingelheim
Daiichi Sankyo

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017876

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NDA 017876 describes LOESTRIN 21 1/20, 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 21 1/20 profile page.

The generic ingredient in LOESTRIN 21 1/20 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 017876
Tradename:LOESTRIN 21 1/20
Ingredient:ethinyl estradiol; norethindrone acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017876
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOESTRIN 21 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 017876 NDA AUTHORIZED GENERIC Mayne Pharma Inc. 51862-007 N 51862-007-06
LOESTRIN 21 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 017876 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 52544-276 N 52544-276-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.02MG;1MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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