Details for New Drug Application (NDA): 203125
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NDA 203125 describes METHYLPREDNISOLONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Amneal, Bedford Labs, Elkins Sinn, Eugia Pharma, Fresenius Kabi Usa, Hikma, Intl Medication, Sagent Pharms Inc, Teva Parenteral, Tianjin Kingyork, and Watson Labs, and is included in thirty-three NDAs. It is available from seven suppliers. Additional details are available on the METHYLPREDNISOLONE SODIUM SUCCINATE profile page.
The generic ingredient in METHYLPREDNISOLONE SODIUM SUCCINATE is methylprednisolone sodium succinate. There are forty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the methylprednisolone sodium succinate profile page.
The generic ingredient in METHYLPREDNISOLONE SODIUM SUCCINATE is methylprednisolone sodium succinate. There are forty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the methylprednisolone sodium succinate profile page.
Summary for 203125
| Tradename: | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Applicant: | Hikma |
| Ingredient: | methylprednisolone sodium succinate |
| Patents: | 0 |
Pharmacology for NDA: 203125
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 203125
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE SODIUM SUCCINATE | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 203125 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9753 | 0143-9753-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9753-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| METHYLPREDNISOLONE SODIUM SUCCINATE | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 203125 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9754 | 0143-9754-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9754-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9754-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/VIAL | ||||
| Approval Date: | Sep 26, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 125MG BASE/VIAL | ||||
| Approval Date: | Sep 26, 2022 | TE: | AP | RLD: | No | ||||
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