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Boehringer Ingelheim
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Generated: January 15, 2019

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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-five drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 083231
Applicant:Crown Labs
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 0316-0140-02 1.5 mL in 1 POUCH (0316-0140-02)

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:

Boehringer Ingelheim
Fish and Richardson
Daiichi Sankyo

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