Last Updated: August 8, 2026

Details for New Drug Application (NDA): 203810

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NDA 203810 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, Appco, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hibrow Hlthcare, Hikma Intl Pharms, 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, Fera Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette Pharms Nc, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin, The J Molner, Cmp Pharma Inc, Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Zydus Pharms, Encube Ethicals, and Padagis Israel, and is included in one hundred and thirty-eight NDAs. It is available from thirty suppliers. Additional details are available on the HYDROCORTISONE profile page.

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

Summary for 203810

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

Pharmacology for NDA: 203810

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 203810

Anti-Inflammatory Agents

Suppliers and Packaging for NDA: 203810

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	203810	ANDA	Encube Ethicals, Inc.	21922-065	21922-065-05	1 TUBE in 1 CARTON (21922-065-05) / 30 g in 1 TUBE
HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	203810	ANDA	Encube Ethicals, Inc.	21922-065	21922-065-30	453.6 g in 1 JAR (21922-065-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	2.5%
Approval Date:	Jul 23, 2018	TE:		RLD:	No

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