Details for New Drug Application (NDA): 207481
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NDA 207481 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Amneal, Chartwell Rx, Duramed Pharms Barr, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Ph Health, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Epic Pharma Llc, Eugia Pharma, Hikma, Hong Kong, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in seventy NDAs. It is available from twenty-six suppliers. Additional details are available on the METHYLPREDNISOLONE profile page.
The generic ingredient in METHYLPREDNISOLONE is methylprednisolone acetate. There are forty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
The generic ingredient in METHYLPREDNISOLONE is methylprednisolone acetate. There are forty drug master file entries for this compound. Ten 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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