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, Hikma, Hong Kong, Ph Health, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in eighteen NDAs. It is available from eight 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 214870
| Tradename: | METHYLPREDNISOLONE ACETATE |
| Applicant: | Wilshire Pharms Inc |
| Ingredient: | methylprednisolone acetate |
| Patents: | 0 |
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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