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Cantor Fitzgerald
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Federal Trade Commission
Argus Health
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Fuji
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017355

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NDA 017355 describes LOESTRIN FE 1.5/30, 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 FE 1.5/30 profile page.

The generic ingredient in LOESTRIN FE 1.5/30 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 017355
Tradename:LOESTRIN FE 1.5/30
Applicant:Apil
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017355
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOESTRIN FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 017355 NDA AUTHORIZED GENERIC Mayne Pharma Inc. 51862-292 N 51862-292-06
LOESTRIN FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 017355 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 52544-233 N 52544-233-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;1.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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