Details for New Drug Application (NDA): 207481
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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 207481
Tradename: | METHYLPREDNISOLONE |
Applicant: | Amneal |
Ingredient: | methylprednisolone |
Patents: | 0 |
Pharmacology for NDA: 207481
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 207481
Suppliers and Packaging for NDA: 207481
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE | methylprednisolone | TABLET;ORAL | 207481 | ANDA | Amneal Pharmaceuticals LLC | 65162-871 | 65162-871-10 | 100 TABLET in 1 BOTTLE (65162-871-10) |
METHYLPREDNISOLONE | methylprednisolone | TABLET;ORAL | 207481 | ANDA | Amneal Pharmaceuticals LLC | 65162-871 | 65162-871-40 | 1 BLISTER PACK in 1 CARTON (65162-871-40) / 21 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Sep 21, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Sep 21, 2021 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
Approval Date: | Sep 21, 2021 | TE: | RLD: | No |
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