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Last Updated: January 29, 2020

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Details for New Drug Application (NDA): 203667

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NDA 203667 describes MINASTRIN 24 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 and one Paragraph IV challenge. Additional details are available on the MINASTRIN 24 FE profile page.

The generic ingredient in MINASTRIN 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 203667
Tradename:MINASTRIN 24 FE
Applicant:Apil
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:1
Suppliers and Packaging for NDA: 203667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667 NDA Allergan, Inc. 0430-0540 0430-0540-50 5 BLISTER PACK in 1 CARTON (0430-0540-50) > 1 KIT in 1 BLISTER PACK
MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 52544-058 52544-058-72 5 POUCH in 1 CARTON (52544-058-72) > 1 BLISTER PACK in 1 POUCH (52544-058-41) > 1 KIT in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 203667
Tradename Dosage Ingredient NDA Submissiondate
MINASTRIN 24 FE TABLET, CHEWABLE;ORAL ethinyl estradiol; norethindrone acetate 203667 2014-04-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.02MG;1MG
Approval Date:May 8, 2013TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 6, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

Expired US Patents for NDA 203667

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013   Start Trial   Start Trial
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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