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MINASTRIN 24 FE Drug Profile

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Minastrin 24 Fe is a drug marketed by Apil and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in MINASTRIN 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for Tradename: MINASTRIN 24 FE

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: MINASTRIN 24 FE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
MINASTRIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL203667-001May 8, 2013RXYes6,667,050<disabled>Y <disabled>
Apil
MINASTRIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL203667-001May 8, 2013RXYes<disabled><disabled>
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Expired Patents for Tradename: MINASTRIN 24 FE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
MINASTRIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL203667-001May 8, 20135,552,394<disabled>
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Paragraph IV activity for: MINASTRIN 24 FE

Drugname Dosage Strength RLD Submissiondate
norethindrone acetate and ethinyl estradiol and ferrous fumarateChewable Tablets1 mg/0.02 mg and 75 mgMinastrin 24 Fe4/23/2014
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