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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 206807

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NDA 206807 describes NORETHINDRONE, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Naari Pte Ltd, Novast Labs, Xiromed, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Dr Reddys Labs Sa, Apotex, Watson Labs, Watson Pharms Teva, Mylan Labs Ltd, Watson Labs Teva, and Teva Branded Pharm, and is included in sixty-three NDAs. It is available from nine suppliers. 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. Additional details are available on the mestranol; norethindrone profile page.

Summary for 206807

Tradename:	NORETHINDRONE
Applicant:	Naari Pte Ltd
Ingredient:	norethindrone
Patents:	0

Pharmacology for NDA: 206807

Medical Subject Heading (MeSH) Categories for 206807

Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 206807

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORETHINDRONE	norethindrone	TABLET;ORAL-28	206807	ANDA	Naari Pte. Limited	79929-015	79929-015-07	84 BLISTER PACK in 1 CARTON (79929-015-07) / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.35MG
Approval Date:	Dec 13, 2016	TE:	AB1	RLD:	No

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