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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201108

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NDA 201108 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 201108

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 201108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 201108 ANDA OHM LABORATORIES INC. 51660-572 51660-572-86 1 KIT in 1 CARTON (51660-572-86) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 201108 ANDA Amneal Pharmaceuticals LLC 60219-1531 60219-1531-6 1 BLISTER PACK in 1 CARTON (60219-1531-6) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG;0.1MG
Approval Date:Feb 5, 2014TE:AB1RLD:No


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AstraZeneca
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