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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
UBS
Julphar
Farmers Insurance
Healthtrust
Fuji
QuintilesIMS
Federal Trade Commission
Medtronic

Generated: December 15, 2017

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-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 202260

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 202260

Ingredient-typeProgesterone Congeners

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 51660-127-86 1 BLISTER PACK in 1 CARTON (51660-127-86) > 28 TABLET, FILM COATED in 1 BLISTER PACK
NORETHINDRONE norethindrone TABLET;ORAL-28 202260 ANDA Amneal Pharmaceuticals LLC 69238-1583 69238-1583-6 1 BLISTER PACK in 1 CARTON (69238-1583-6) > 1 KIT in 1 BLISTER PACK

Summary 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 leading biopharmaceutical companies globally:

Novartis
Teva
Medtronic
Queensland Health
Boehringer Ingelheim
AstraZeneca
Harvard Business School
Mallinckrodt
Fuji
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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