.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
McKinsey
Julphar
Merck
Argus Health
Fish and Richardson
Boehringer Ingelheim
Moodys
Covington

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076761

« Back to Dashboard

NDA 076761 describes OXANDROLONE, which is a drug marketed by Par Pharm, Roxane, Sandoz, and Upsher-smith Labs, and is included in five NDAs. It is available from three suppliers. Additional details are available on the OXANDROLONE profile page.

The generic ingredient in OXANDROLONE is oxandrolone. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.

Summary for 076761

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 076761

Suppliers and Packaging for NDA: 076761

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXANDROLONE oxandrolone TABLET;ORAL 076761 ANDA Upsher-Smith Laboratories, LLC 0245-0271 0245-0271-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0245-0271-01) > 1 TABLET in 1 BLISTER PACK (0245-0271-89)
OXANDROLONE oxandrolone TABLET;ORAL 076761 ANDA Upsher-Smith Laboratories, LLC 0245-0271 0245-0271-11 100 TABLET in 1 BOTTLE (0245-0271-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 1, 2006TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fuji
Queensland Health
McKinsey
Baxter
Julphar
Merck
QuintilesIMS
Boehringer Ingelheim
Moodys

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot