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Details for New Drug Application (NDA): 040611

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NDA 040611 describes PREDNISONE, which is a drug marketed by Halsey, Roxane, Marshall Pharma, Mutual Pharm, Vangard, Inwood Labs, Vitarine, Phoenix Labs Ny, Contract Pharmacal, Elkins Sinn, Jubilant Cadista, Aurolife Pharma Llc, Watson Labs, Whiteworth Town Plsn, Lannett, Nylos, Heather, Wockhardt, Delcor Asset Corp, Rexall, Ivax Sub Teva Pharms, Kv Pharm, Sandoz, Valeant Pharm Intl, Hikma Pharms, Everylife, Sun Pharm Inds, Panray, Pvt Form, Purepac Pharm, Vintage Pharms, Perrigo, Sperti, Pharmavite, Ferrante, Superpharm, Lederle, Upsher Smith, Scherer Labs, Bundy, Impax Labs, UDL, Am Therap, Duramed Pharms Barr, Amneal Pharms Ny, and Teva, and is included in one hundred and six NDAs. It is available from fifty-eight suppliers. Additional details are available on the PREDNISONE profile page.

The generic ingredient in PREDNISONE is prednisone. There are fifteen drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for NDA: 040611

Suppliers and Packaging for NDA: 040611

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 040611 ANDA JUBILANT CADISTA PHARMACEUTICALS, INC. 59746-171 59746-171-06 100 TABLET in 1 BOTTLE (59746-171-06)
TABLET;ORAL 040611 ANDA JUBILANT CADISTA PHARMACEUTICALS, INC. 59746-171 59746-171-10 1000 TABLET in 1 BOTTLE (59746-171-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 6, 2005TE:ABRLD:No

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