BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • 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:

Daiichi Sankyo
Queensland Health
US Army
Boehringer Ingelheim
Farmers Insurance
Express Scripts

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040396

« Back to Dashboard

NDA 040396 describes MICORT-HC, which is a drug marketed by Sebela Ireland Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the MICORT-HC profile page.

The generic ingredient in MICORT-HC is hydrocortisone acetate. There are sixty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.

Summary for 040396

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 040396

Suppliers and Packaging for NDA: 040396

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICORT-HC hydrocortisone acetate CREAM;TOPICAL 040396 ANDA Sebela Pharmaceuticals Inc. 54766-835 54766-835-98 12 TUBE, WITH APPLICATOR in 1 CARTON (54766-835-98) > 4 g in 1 TUBE, WITH APPLICATOR (54766-835-90)
MICORT-HC hydrocortisone acetate CREAM;TOPICAL 040396 ANDA Sebela Pharmaceuticals Inc. 54766-835 54766-835-04 28.4 g in 1 TUBE, WITH APPLICATOR (54766-835-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Feb 27, 2001TE:RLD: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:

US Department of Justice

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: