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Details for New Drug Application (NDA): 200961

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NDA 200961 describes NORETHINDRONE, which is a drug marketed by Glenmark Generics, Novast Labs Ltd, Lupin Ltd, Amneal Pharms, Novast Labs, Jai Pharma Ltd, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Mayne Pharma, Glenmark Pharms Ltd, Watson Labs, and Apil, and is included in forty-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 NDA: 200961

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

Suppliers and Packaging for NDA: 200961

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE
norethindrone
TABLET;ORAL-28 200961 ANDA Northstar Rx LLC 16714-073 16714-073-01 1 BLISTER PACK in 1 PACKET (16714-073-01) > 1 KIT in 1 BLISTER PACK
NORETHINDRONE
norethindrone
TABLET;ORAL-28 200961 ANDA Northstar Rx LLC 16714-073 16714-073-02 1 BLISTER PACK in 1 CARTON (16714-073-02) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Sep 13, 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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