Details for New Drug Application (NDA): 040557
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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 040557
Tradename: | METHYLPREDNISOLONE ACETATE |
Applicant: | Hong Kong |
Ingredient: | methylprednisolone acetate |
Patents: | 0 |
Pharmacology for NDA: 040557
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 040557
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 040557 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1429 | 51662-1429-1 | 1 mL in 1 VIAL, SINGLE-DOSE (51662-1429-1) |
METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 040557 | ANDA | Proficient Rx LP | 63187-474 | 63187-474-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63187-474-01) / 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: | Feb 23, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
Approval Date: | Feb 23, 2005 | TE: | AB | RLD: | No |
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