Details for New Drug Application (NDA): 083231
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NDA 083231 describes ALA-SCALP, which is a drug marketed by Legacy Pharma 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-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
The generic ingredient in ALA-SCALP is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 083231
| Tradename: | ALA-SCALP |
| Applicant: | Legacy Pharma |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 083231
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 | Allegis Holdings LLC | 71297-010 | 71297-010-01 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-01) / 29.6 mL in 1 BOTTLE, WITH APPLICATOR |
| ALA-SCALP | hydrocortisone | LOTION;TOPICAL | 083231 | ANDA | Allegis Holdings LLC | 71297-010 | 71297-010-02 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-02) / 59.2 mL in 1 BOTTLE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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