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Generated: November 18, 2017

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Details for New Drug Application (NDA): 200980

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NDA 200980 describes NORETHINDRONE, which is a drug marketed by Accord Hlthcare, Glenmark Generics, Novast Labs Ltd, Lupin Ltd, Amneal Pharms, Novast Labs, Mylan Labs Ltd, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Mayne Pharma, Glenmark Pharms Ltd, 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 200980

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: 200980

Ingredient-typeProgesterone Congeners

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 0378-7272-53 3 POUCH in 1 CARTON (0378-7272-53) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK
NORETHINDRONE
norethindrone
TABLET;ORAL-28 200980 ANDA Afaxys Pharma LLC 50102-100 50102-100-03 3 PACKAGE in 1 CARTON (50102-100-03) > 1 BLISTER PACK in 1 PACKAGE (50102-100-10) > 28 TABLET in 1 BLISTER PACK (50102-100-00)

Summary for product number 001

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


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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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