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Julphar
Cantor Fitzgerald
Baxter
Mallinckrodt
Express Scripts
Cipla
Fuji
Moodys
Colorcon

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200980

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NDA 200980 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, Apotex Inc, Watson Labs, Watson Pharms Teva, Watson Labs Teva, and Apil, and is included in fifty-eight NDAs. It is available from eleven 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 200980
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: 200980
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 200980
Suppliers and Packaging for NDA: 200980
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE norethindrone TABLET;ORAL-28 200980 ANDA Mylan Pharmaceuticals Inc. 0378-7272 N 0378-7272-53
NORETHINDRONE norethindrone TABLET;ORAL-28 200980 ANDA Afaxys Pharma LLC 50102-100 N 50102-100-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Jun 12, 2013TE:AB2RLD:No

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