Details for New Drug Application (NDA): 213386
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NDA 213386 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 fifty 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-one 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-one suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 213386
| Tradename: | PREDNISONE |
| Applicant: | Amneal |
| Ingredient: | prednisone |
| Patents: | 0 |
Pharmacology for NDA: 213386
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 213386
Suppliers and Packaging for NDA: 213386
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | prednisone | TABLET;ORAL | 213386 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8440 | 0615-8440-05 | 15 TABLET in 1 BLISTER PACK (0615-8440-05) |
| PREDNISONE | prednisone | TABLET;ORAL | 213386 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8440 | 0615-8440-39 | 30 TABLET in 1 BLISTER PACK (0615-8440-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 24, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 24, 2020 | TE: | AB | RLD: | No | ||||
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