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Details for New Drug Application (NDA): 079218

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NDA 079218 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Mayne Pharma, Amneal Pharms, Watson Labs, Lupin Ltd, Jai Pharma Ltd, Barr, Glenmark Pharms Ltd, Haupt Pharma, and Glenmark Generics, and is included in twenty-two NDAs. It is available from eleven suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for NDA: 079218

Pharmacology for NDA: 079218

Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Physiological EffectInhibit Ovum Fertilization

Suppliers and Packaging for NDA: 079218

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; levonorgestrel
TABLET;ORAL 079218 ANDA Watson Pharma, Inc. 52544-295 52544-295-28 1 BLISTER PACK in 1 CARTON (52544-295-28) > 28 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;0.09MG
Approval Date:Jun 6, 2011TE:ABRLD:Yes

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