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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Covington
Chinese Patent Office
Baxter
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Dow
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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201483

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NDA 201483 describes NORETHINDRONE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Glenmark Generics, Lupin Ltd, Mylan Labs Ltd, Novast Labs, Novast Labs Ltd, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Glenmark Pharms Ltd, Mayne Pharma, Watson Labs, Watson Pharms Teva, Watson Labs Teva, and Apil, and is included in fifty-five NDAs. It is available from ten suppliers. There is one patent protecting this drug. Additional details are available on the NORETHINDRONE profile page.

The generic ingredient in NORETHINDRONE is mestranol; norethindrone. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mestranol; norethindrone profile page.
Summary for 201483
Tradename:NORETHINDRONE
Applicant:Mylan Labs Ltd
Ingredient:norethindrone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 201483
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 201483
Suppliers and Packaging for NDA: 201483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE norethindrone TABLET;ORAL-28 201483 ANDA Mylan Pharmaceuticals Inc. 0378-7292 0378-7292-53 3 POUCH in 1 CARTON (0378-7292-53) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK
NORETHINDRONE norethindrone TABLET;ORAL-28 201483 ANDA Mylan Pharmaceuticals Inc. 0378-7292 0378-7292-56 6 POUCH in 1 CARTON (0378-7292-56) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Jun 24, 2013TE:AB1RLD:No

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Deloitte
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Cipla
Federal Trade Commission
Cantor Fitzgerald

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