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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Harvard Business School
Queensland Health
Boehringer Ingelheim

Generated: April 25, 2018

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 three suppliers. 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. Thirty suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 202635
Applicant:Sun Pharm Inds Ltd
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202635
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 Rugby Laboratories 0536-1142 N 0536-1142-63
OPCICON ONE-STEP levonorgestrel TABLET;ORAL 202635 ANDA Sun Pharmaceutical Industries Limited 62756-718 N 62756-718-60

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
US Department of Justice
Argus Health

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