Details for New Drug Application (NDA): 214870
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NDA 214870 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Epic Pharma Llc, Eugia Pharma, Hong Kong, Par Sterile Products, Sagent Pharms Inc, Sandoz, Slayback Pharma Llc, Teva Pharms Usa, and Watson Labs, and is included in seventeen NDAs. It is available from nine suppliers. Additional details are available on the METHYLPREDNISOLONE ACETATE profile page.
The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 214870
| Tradename: | METHYLPREDNISOLONE ACETATE |
| Applicant: | Slayback Pharma Llc |
| Ingredient: | methylprednisolone acetate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214870
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 214870
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 214870 | ANDA | Sandoz Inc. | 0781-3516 | 0781-3516-75 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3516-75) / 5 mL in 1 VIAL, MULTI-DOSE |
| METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 214870 | ANDA | Sandoz Inc. | 0781-3522 | 0781-3522-70 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-70) / 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
| Approval Date: | Jan 3, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
| Approval Date: | May 10, 2023 | TE: | AB | RLD: | No | ||||
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