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Serving 500+ biopharmaceutical companies globally:

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Generated: July 27, 2017

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

Summary for NDA: 017876

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 51862-007-06 6 BLISTER PACK in 1 CARTON (51862-007-06) > 21 TABLET in 1 BLISTER PACK
LOESTRIN 21 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21 017876 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 52544-276 52544-276-21 6 BLISTER PACK in 1 CARTON (52544-276-21) > 21 TABLET in 1 BLISTER PACK

Summary 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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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Harvard Business School

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