Details for New Drug Application (NDA): 206751
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The generic ingredient in METHYLPREDNISOLONE 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 206751
Tradename: | METHYLPREDNISOLONE |
Applicant: | Zydus Pharms |
Ingredient: | methylprednisolone |
Patents: | 0 |
Pharmacology for NDA: 206751
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206751
Suppliers and Packaging for NDA: 206751
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE | methylprednisolone | TABLET;ORAL | 206751 | ANDA | Major Pharmaceuticals | 0904-6914 | 0904-6914-61 | 100 BLISTER PACK in 1 CARTON (0904-6914-61) / 1 TABLET in 1 BLISTER PACK |
METHYLPREDNISOLONE | methylprednisolone | TABLET;ORAL | 206751 | ANDA | A-S Medication Solutions | 50090-3811 | 50090-3811-0 | 1 BLISTER PACK in 1 CARTON (50090-3811-0) / 21 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Apr 23, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Apr 23, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
Approval Date: | Apr 23, 2018 | TE: | AB | RLD: | No |
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