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Fuji
Queensland Health
UBS
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Boehringer Ingelheim
Cerilliant
Moodys
Cipla
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080706

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NDA 080706 describes ALA-CORT, which is a drug marketed by Crown Labs and is included in two NDAs. It is available from three suppliers. Additional details are available on the ALA-CORT profile page.

The generic ingredient in ALA-CORT is hydrocortisone. There are sixty-four drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 080706
Tradename:ALA-CORT
Applicant:Crown Labs
Ingredient:hydrocortisone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 080706
Medical Subject Heading (MeSH) Categories for 080706
Suppliers and Packaging for NDA: 080706
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0126 N 0316-0126-01
ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0126 N 0316-0126-03

Profile for product number 006

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

Profile for product number 007

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Jan 5, 2016TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKinsey
Cantor Fitzgerald
US Department of Justice
Farmers Insurance
Teva
Federal Trade Commission
QuintilesIMS
US Army

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