Last Updated: November 13, 2026

Details for New Drug Application (NDA): 083365

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NDA 083365 describes HYDROCORTISONE, which is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Teva Pharms, Fougera Pharms, Mericon, Sun Pharma Canada, Paddock Llc, Adaptis, Appco, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hikma, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Novitium Pharma, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Strides Pharma Intl, Watson Labs, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Sciegen Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette Pharms Nc, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin, The J Molner, Pharmobedient, Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Zydus Pharms, Encube Ethicals, and Padagis Israel, and is included in one hundred and thirty-nine NDAs. It is available from thirty-one suppliers. Additional details are available on the HYDROCORTISONE profile page.

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

Summary for 083365

Tradename:	HYDROCORTISONE
Applicant:	Hikma
Ingredient:	hydrocortisone
Patents:	0

Medical Subject Heading (MeSH) Categories for 083365

Anti-Inflammatory Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 23, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 23, 2015	TE:		RLD:	No

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