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Serving leading biopharmaceutical companies globally:

Accenture
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Generated: November 23, 2017

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 two suppliers. Additional details are available on the ALA-SCALP profile page.

The generic ingredient in ALA-SCALP is hydrocortisone. There are sixty drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

Summary for 083231

Tradename:
1
Applicant:
1
Ingredient:
1
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 0316-0140-01 29.6 mL in 1 BOTTLE, DROPPER (0316-0140-01)
ALA-SCALP
hydrocortisone
LOTION;TOPICAL 083231 ANDA Crown Laboratories 0316-0140 0316-0140-03 3 mL in 1 POUCH (0316-0140-03)

Summary 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 leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Mallinckrodt
Harvard Business School
Fuji
Federal Trade Commission
Moodys
Cerilliant
Dow
McKesson

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.

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