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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Argus Health
Boehringer Ingelheim
Deloitte
US Department of Justice
Fish and Richardson
Federal Trade Commission
Colorcon
McKesson
Daiichi Sankyo

Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202635

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NDA 202635 describes OPCICON ONE-STEP, which is a drug marketed by Sun Pharm Inds Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the OPCICON ONE-STEP profile page.

The generic ingredient in OPCICON ONE-STEP is levonorgestrel. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

Summary for NDA: 202635

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202635

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPCICON ONE-STEP
levonorgestrel
TABLET;ORAL 202635 ANDA Sun Pharmaceutical Industries Limited 62756-718 62756-718-60 1 BLISTER PACK in 1 CARTON (62756-718-60) > 1 TABLET in 1 BLISTER PACK
OPCICON ONE-STEP
levonorgestrel
TABLET;ORAL 202635 ANDA Sun Pharmaceutical Industries Limited 62756-720 62756-720-60 1 BLISTER PACK in 1 CARTON (62756-720-60) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.5MG
Approval Date:Sep 11, 2014TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
QuintilesIMS
Fish and Richardson
Daiichi Sankyo
Merck
Argus Health
Express Scripts
Cipla
Teva
Citi

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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