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Generated: May 23, 2017

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Details for New Drug Application (NDA): 078323

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NDA 078323 describes NORETHINDRONE AND ETHINYL ESTRADIOL, which is a drug marketed by Mylan Labs Ltd, Watson Labs, Accord Hlthcare, Watson Pharms Teva, Mayne Pharma, Lupin Ltd, Barr, Apil, and Amneal Pharms, and is included in twenty-four NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL profile page.

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

Summary for NDA: 078323

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078323

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; norethindrone
TABLET;ORAL-28 078323 ANDA Watson Pharma, Inc. 52544-953 52544-953-28 6 BLISTER PACK in 1 CARTON (52544-953-28) > 1 KIT in 1 BLISTER PACK
ethinyl estradiol; norethindrone
TABLET;ORAL-28 078323 ANDA Physicians Total Care, Inc. 54868-6273 54868-6273-0 1 BLISTER PACK in 1 CARTON (54868-6273-0) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.4MG
Approval Date:Feb 4, 2010TE:ABRLD:No

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