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 six 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-six suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
The generic ingredient in ALA-CORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 080706
| Tradename: | ALA-CORT |
| Applicant: | Crown Labs |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 080706
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
Profile for product number 007
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2.5% | ||||
| Approval Date: | Jan 5, 2016 | TE: | AT | RLD: | No | ||||
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