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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091325


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NDA 091325 describes NORETHINDRONE, which is a drug marketed by Amneal Pharms, Glenmark Generics, Lupin Ltd, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Glenmark Pharms Ltd, Dr Reddys Labs Sa, Mylan, Apotex, Xiromed, Watson Labs, Watson Pharms Teva, Watson Labs Teva, and Apil, and is included in sixty-three NDAs. It is available from seven 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 091325
Tradename:NORETHINDRONE
Applicant:Lupin Ltd
Ingredient:norethindrone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091325
Medical Subject Heading (MeSH) Categories for 091325
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 A-S Medication Solutions 50090-6161 50090-6161-0 1 BLISTER PACK in 1 CARTON (50090-6161-0) / 28 TABLET in 1 BLISTER PACK
NORETHINDRONE norethindrone TABLET;ORAL-28 091325 ANDA Lupin Pharmaceuticals, Inc. 68180-876 68180-876-73 3 BLISTER PACK in 1 CARTON (68180-876-73) / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

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

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