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Last Updated: July 7, 2020

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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 five suppliers. Additional details are available on the ALA-CORT profile page.

The generic ingredient in ALA-CORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 080706
Applicant:Crown Labs
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 0316-0126-01 1 TUBE in 1 CARTON (0316-0126-01) > 28.4 g in 1 TUBE
ALA-CORT hydrocortisone CREAM;TOPICAL 080706 ANDA Crown Laboratories 0316-0126 0316-0126-03 1 TUBE in 1 CARTON (0316-0126-03) > 85.2 g in 1 TUBE

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 leading biopharmaceutical companies globally:

Boehringer Ingelheim
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