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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091325

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NDA 091325 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 091325

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: 091325

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 091325

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE norethindrone TABLET;ORAL-28 091325 ANDA LUPIN LIMITED 57297-876 57297-876-13 3 BLISTER PACK in 1 CARTON (57297-876-13) > 28 TABLET in 1 BLISTER PACK (57297-876-11)
NORETHINDRONE norethindrone TABLET;ORAL-28 091325 ANDA Lupin Pharmaceuticals, Inc. 68180-876 68180-876-13 3 BLISTER PACK in 1 CARTON (68180-876-13) > 28 TABLET in 1 BLISTER PACK (68180-876-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Sep 19, 2011TE:AB1RLD:No


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