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Details for New Drug Application (NDA): 202691
NDA 202691 describes METHYLPREDNISOLONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Amneal Pharms Co, Aurobindo Pharma Ltd, Bedford Labs, Elkins Sinn, Fresenius Kabi Usa, Hikma Farmaceutica, Intl Medication, Sagent Pharms, Teva Parenteral, and Watson Labs, and is included in thirty-one NDAs. It is available from five 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone sodium succinate profile page.
Summary for 202691
| Tradename: | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | methylprednisolone sodium succinate |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) Inflammatory Bowel Disease Agents |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Feb 16, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Feb 16, 2016 | TE: | AP | RLD: | No | ||||
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