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Details for New Drug Application (NDA): 080456

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NDA 080456 describes HYDROCORTISONE, which is a drug marketed by Teva, Vintage Pharms, Fougera, Naska, Taro, Pharmaderm, Alpharma Us Pharms, Elkins Sinn, Perrigo New York, Syosset, Usl Pharma, Pharmaceutics Intl, Inwood Labs, Ivax Pharms, Pharmafair, Roxane, Nexgen Pharma Inc, Sandoz, Parke Davis, Whiteworth Town Plsn, Amedra Pharms, Purepac Pharm, Altana, Fougera Pharms, Everylife, Watson Labs, Ingram Pharm, G And W Labs, Panray, Vintage, Hikma Intl Pharms, Ferrante, Stiefel, Lannett, Ambix, Teva Pharms, Topiderm, Rising Pharms Inc, Impax Labs, Actavis Mid Atlantic, Mericon, Paddock Llc, Barr, Cenci, Fera Pharms, Akorn, Bel Mar, Ferndale Labs, X Gen Pharms, Wockhardt, Bausch And Lomb, Glenmark Generics, Taro Pharm Inds, Carolina Medcl, Abraxis Pharm, Baxter Hlthcare, Intl Medication, and G And W Labs Inc, and is included in one hundred and twenty NDAs. It is available from thirty-five suppliers. Additional details are available on the HYDROCORTISONE profile page.

The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are fifty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.

Summary for NDA: 080456

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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