Details for New Drug Application (NDA): 040775
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NDA 040775 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, Bel Mar, Cent Pharms, Epic Pharma Llc, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Mission Pharma, Vintage, Vintage Pharms, and Xttrium Labs Inc, and is included in eighty-five NDAs. It is available from six 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 040775
| Tradename: | PREDNISOLONE |
| Applicant: | Lannett Co Inc |
| Ingredient: | prednisolone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040775
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040775
Suppliers and Packaging for NDA: 040775
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISOLONE | prednisolone | SYRUP;ORAL | 040775 | ANDA | Lannett Company, Inc. | 0527-5406 | 0527-5406-68 | 240 mL in 1 BOTTLE (0527-5406-68) |
| PREDNISOLONE | prednisolone | SYRUP;ORAL | 040775 | ANDA | Lannett Company, Inc. | 0527-5406 | 0527-5406-70 | 480 mL in 1 BOTTLE (0527-5406-70) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML | ||||
| Approval Date: | Sep 21, 2007 | TE: | AA | RLD: | No | ||||
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