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Serving leading biopharmaceutical companies globally:

Medtronic
Teva
Baxter
AstraZeneca
Chubb
Covington
Fuji
McKesson
QuintilesIMS
Johnson and Johnson

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083231

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NDA 083231 describes ALA-SCALP, which is a drug marketed by Crown Labs and is included in one NDA. It is available from one supplier. Additional details are available on the ALA-SCALP profile page.

The generic ingredient in ALA-SCALP 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 083231
Tradename:ALA-SCALP
Applicant:Crown Labs
Ingredient:hydrocortisone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 083231
Medical Subject Heading (MeSH) Categories for 083231
Suppliers and Packaging for NDA: 083231
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALA-SCALP hydrocortisone LOTION;TOPICAL 083231 ANDA Crown Laboratories 0316-0140 N 0316-0140-02
ALA-SCALP hydrocortisone LOTION;TOPICAL 083231 ANDA Crown Laboratories 0316-0140 N 0316-0140-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
QuintilesIMS
Argus Health
Fish and Richardson
Daiichi Sankyo
Cerilliant
Healthtrust
Teva
Baxter

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