Details for New Drug Application (NDA): 214297
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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 214297
Tradename: | METHYLPREDNISOLONE ACETATE |
Applicant: | Endo Operations |
Ingredient: | methylprednisolone acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214297
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 214297
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 214297 | ANDA | Par Pharmaceutical, Inc. | 42023-238 | 42023-238-01 | 1 VIAL in 1 CARTON (42023-238-01) / 5 mL in 1 VIAL |
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 214297 | ANDA | Par Pharmaceutical, Inc. | 42023-239 | 42023-239-01 | 1 VIAL in 1 CARTON (42023-239-01) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
Approval Date: | Jan 21, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
Approval Date: | Jan 21, 2022 | TE: | AB | RLD: | No |
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