Details for New Drug Application (NDA): 210043
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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 210043
Tradename: | METHYLPREDNISOLONE ACETATE |
Applicant: | Amneal |
Ingredient: | methylprednisolone acetate |
Patents: | 0 |
Pharmacology for NDA: 210043
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 210043
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 210043 | ANDA | A-S Medication Solutions | 50090-5894 | 50090-5894-0 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50090-5894-0) / 1 mL in 1 VIAL, SINGLE-DOSE |
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 210043 | ANDA | A-S Medication Solutions | 50090-6024 | 50090-6024-0 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50090-6024-0) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
Approval Date: | May 20, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
Approval Date: | May 20, 2019 | TE: | AB | RLD: | No |
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