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Generated: June 25, 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 Mayne Pharma, Amneal Pharms, Watson Labs, Lupin Ltd, Mylan Labs Ltd, Barr, Glenmark Pharms Ltd, and Glenmark Generics, and is included in twenty-two 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-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for NDA: 201108

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 69238-1531 69238-1531-6 1 BLISTER PACK in 1 CARTON (69238-1531-6) > 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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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
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Covington
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Cantor Fitzgerald
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Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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