Details for New Drug Application (NDA): 214870
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The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Twelve 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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