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Last Updated: October 23, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022501


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NDA 022501 describes LO LOESTRIN FE, which is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the LO LOESTRIN FE profile page.

The generic ingredient in LO LOESTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 022501
Tradename:LO LOESTRIN FE
Applicant:Apil
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:1
Suppliers and Packaging for NDA: 022501
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501 NDA Allergan, Inc. 0430-0420 0430-0420-14 5 BLISTER PACK in 1 CARTON (0430-0420-14) > 1 KIT in 1 BLISTER PACK
LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501 NDA Allergan, Inc. 0430-0420 0430-0420-60 8 CARTON in 1 TRAY (0430-0420-60) > 30 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 022501
Tradename Dosage Ingredient NDA Submissiondate
LO LOESTRIN FE TABLET;ORAL ethinyl estradiol; norethindrone acetate 022501 2011-04-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.01MG,0.01MG;1MG,N/A
Approval Date:Oct 21, 2010TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Feb 2, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION

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