BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
US Army
Boehringer Ingelheim
Fish and Richardson
Express Scripts

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202260

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NDA 202260 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-seven 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 202260
Applicant:Amneal Pharms
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 202260
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 202260
Suppliers and Packaging for NDA: 202260
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE norethindrone TABLET;ORAL-28 202260 ANDA Ohm Laboratories Inc. 51660-127 E 51660-127-86
NORETHINDRONE norethindrone TABLET;ORAL-28 202260 ANDA Amneal Pharmaceuticals LLC 69238-1583 N 69238-1583-6

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Aug 1, 2013TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Farmers Insurance
Queensland Health
Daiichi Sankyo

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