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Details for New Drug Application (NDA): 206969

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NDA 206969 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr Labs Inc, Mayne Pharma, Glenmark Generics, Mylan Labs Ltd, Glenmark Pharms Ltd, and Amneal Pharms, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for NDA: 206969

Formulation / Manufacturing:see details

Pharmacology for NDA: 206969

Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 206969

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21 206969 ANDA Glenmark Pharmaceuticals Inc., USA 68462-132 68462-132-81 3 POUCH in 1 CARTON (68462-132-81) > 1 BLISTER PACK in 1 POUCH (68462-132-79) > 21 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.02MG;1MG
Approval Date:Jan 20, 2016TE:ABRLD:No

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