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Generated: April 24, 2017

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Details for New Drug Application (NDA): 201483

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NDA 201483 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, and Apil, and is included in fifty-two 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: 201483

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 201483

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 201483

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL-28 201483 ANDA Mylan Pharmaceuticals Inc. 0378-7292 0378-7292-53 3 POUCH in 1 CARTON (0378-7292-53) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK
TABLET;ORAL-28 201483 ANDA Mylan Pharmaceuticals Inc. 0378-7292 0378-7292-56 6 POUCH in 1 CARTON (0378-7292-56) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Jun 24, 2013TE:AB1RLD:No

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