Details for New Drug Application (NDA): 089074
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NDA 089074 describes STIE-CORT, which is a drug marketed by Padagis Us and is included in two NDAs. It is available from two suppliers. Additional details are available on the STIE-CORT profile page.
The generic ingredient in STIE-CORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
The generic ingredient in STIE-CORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 089074
| Tradename: | STIE-CORT |
| Applicant: | Padagis Us |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 089074
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 089074
Suppliers and Packaging for NDA: 089074
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STIE-CORT | hydrocortisone | LOTION;TOPICAL | 089074 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-937 | 45802-937-16 | 59 mL in 1 BOTTLE (45802-937-16) |
| STIE-CORT | hydrocortisone | LOTION;TOPICAL | 089074 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-937 | 45802-937-26 | 118 mL in 1 BOTTLE (45802-937-26) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 2.5% | ||||
| Approval Date: | Nov 26, 1985 | TE: | RLD: | No | |||||
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