Details for New Drug Application (NDA): 040256
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NDA 040256 describes PREDNISONE, which is a drug marketed by Hikma, Xttrium Labs Inc, Actavis Labs Fl Inc, Allied, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Endo Operations, Everylife, Ferrante, Geneyork Pharms, Halsey, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Sandoz, Scherer Labs, Sperti, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and sixteen NDAs. It is available from forty-nine suppliers. Additional details are available on the PREDNISONE profile page.
The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the prednisone profile page.
The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 040256
| Tradename: | PREDNISONE |
| Applicant: | Endo Operations |
| Ingredient: | prednisone |
| Patents: | 0 |
Pharmacology for NDA: 040256
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040256
Suppliers and Packaging for NDA: 040256
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | prednisone | TABLET;ORAL | 040256 | ANDA | Endo USA, Inc. | 0603-5337 | 0603-5337-15 | 21 TABLET in 1 BOX, UNIT-DOSE (0603-5337-15) |
| PREDNISONE | prednisone | TABLET;ORAL | 040256 | ANDA | Endo USA, Inc. | 0603-5337 | 0603-5337-21 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-5337-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 12, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 12, 2002 | TE: | AB | RLD: | No | ||||
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