Details for New Drug Application (NDA): 009866
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The generic ingredient in SOLU-CORTEF is hydrocortisone sodium succinate. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrocortisone sodium succinate profile page.
Summary for 009866
| Tradename: | SOLU-CORTEF |
| Applicant: | Pharmacia And Upjohn |
| Ingredient: | hydrocortisone sodium succinate |
| Patents: | 0 |
Pharmacology for NDA: 009866
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 009866
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOLU-CORTEF | hydrocortisone sodium succinate | INJECTABLE;INJECTION | 009866 | NDA | Pharmacia & Upjohn Company LLC | 0009-0005 | 0009-0005-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0005-01) / 8 mL in 1 VIAL, SINGLE-DOSE |
| SOLU-CORTEF | hydrocortisone sodium succinate | INJECTABLE;INJECTION | 009866 | NDA | Pharmacia & Upjohn Company LLC | 0009-0011 | 0009-0011-04 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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