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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Johnson and Johnson
Queensland Health

Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040396

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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-four 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
Applicant:Sebela Ireland Ltd
Ingredient:hydrocortisone acetate
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 N 54766-835-98
MICORT-HC hydrocortisone acetate CREAM;TOPICAL 040396 ANDA Sebela Pharmaceuticals Inc. 54766-835 N 54766-835-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Feb 27, 2001TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Argus Health

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