Details for New Drug Application (NDA): 011153
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NDA 011153 describes MEDROL, which is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in three NDAs. It is available from three suppliers. Additional details are available on the MEDROL profile page.
The generic ingredient in MEDROL is methylprednisolone. There are forty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the methylprednisolone profile page.
The generic ingredient in MEDROL is methylprednisolone. There are forty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the methylprednisolone profile page.
Summary for 011153
| Tradename: | MEDROL |
| Applicant: | Pfizer |
| Ingredient: | methylprednisolone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 011153
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 011153
Suppliers and Packaging for NDA: 011153
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEDROL | methylprednisolone | TABLET;ORAL | 011153 | NDA | Pharmacia & Upjohn Company LLC | 0009-0020 | 0009-0020-01 | 100 TABLET in 1 BOTTLE (0009-0020-01) |
| MEDROL | methylprednisolone | TABLET;ORAL | 011153 | NDA | Pharmacia & Upjohn Company LLC | 0009-0022 | 0009-0022-01 | 25 TABLET in 1 BOTTLE (0009-0022-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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