Details for New Drug Application (NDA): 218083
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NDA 218083 describes PREDNISOLONE, which is a drug marketed by Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, We Pharms, Aurobindo Pharma Ltd, Barr, Bundy, Chartwell Molecular, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rising, Roxane, Sperti, Superpharm, Tablicaps, Teva, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Zhejiang Xianju, Bel Mar, Cent Pharms, Epic Pharma Llc, Lupin Ltd, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Endo Operations, Mission Pharma, Pharmobedient, and Vintage Pharms, and is included in eighty-seven NDAs. It is available from nine suppliers. Additional details are available on the PREDNISOLONE profile page.
The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.
The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.
Summary for 218083
| Tradename: | PREDNISOLONE |
| Applicant: | Zhejiang Xianju |
| Ingredient: | prednisolone |
| Patents: | 0 |
Pharmacology for NDA: 218083
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 218083
Suppliers and Packaging for NDA: 218083
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISOLONE | prednisolone | TABLET;ORAL | 218083 | ANDA | Hisun Pharmaceuticals USA, Inc. | 42658-160 | 42658-160-05 | 100 TABLET in 1 BOTTLE (42658-160-05) |
| PREDNISOLONE | prednisolone | TABLET;ORAL | 218083 | ANDA | Zhejiang Xianju Pharmaceutical Co., Ltd. | 60722-5011 | 60722-5011-0 | 100 TABLET in 1 BOTTLE (60722-5011-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 2, 2024 | TE: | AB | RLD: | No | ||||
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