Details for New Drug Application (NDA): 209097
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NDA 209097 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Amneal, Chartwell Rx, Duramed Pharms Barr, Endo Operations, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in sixty-nine NDAs. It is available from twenty-eight 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 209097
| Tradename: | METHYLPREDNISOLONE |
| Applicant: | Chartwell Rx |
| Ingredient: | methylprednisolone |
| Patents: | 0 |
Pharmacology for NDA: 209097
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209097
Suppliers and Packaging for NDA: 209097
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE | methylprednisolone | TABLET;ORAL | 209097 | ANDA | Chartwell RX, LLC | 62135-759 | 62135-759-30 | 30 TABLET in 1 BOTTLE (62135-759-30) |
| METHYLPREDNISOLONE | methylprednisolone | TABLET;ORAL | 209097 | ANDA | Chartwell RX, LLC | 62135-760 | 62135-760-01 | 100 TABLET in 1 BOTTLE (62135-760-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
| Approval Date: | Feb 22, 2019 | TE: | RLD: | No | |||||
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