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Moodys
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200245

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NDA 200245 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Generics, Glenmark Pharms Ltd, Lupin Ltd, Mayne Pharma, Mylan Labs Ltd, Watson Labs, and Barr, and is included in twenty-three NDAs. It is available from twelve 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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 200245
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL
Applicant:Mylan Labs Ltd
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200245
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 200245 ANDA Mylan Pharmaceuticals Inc. 0378-7287 0378-7287-56 6 POUCH in 1 CARTON (0378-7287-56) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 200245 ANDA Mylan Pharmaceuticals Inc. 0378-7287 0378-7287-53 3 POUCH in 1 CARTON (0378-7287-53) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG;0.1MG
Approval Date:Oct 9, 2013TE:AB1RLD:No

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Colorcon
Mallinckrodt
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Citi
US Army
Teva
Argus Health
Farmers Insurance
Cantor Fitzgerald

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