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Generated: September 25, 2018

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Details for New Drug Application (NDA): 040879

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NDA 040879 describes HYDROCORTISONE, which is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Lannett Co Inc, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising Pharms, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Teva Pharms, Fougera Pharms, Mericon, Paddock Llc, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Lannett, Nexgen Pharma Inc, Panray, Parke Davis, PII, Purepac Pharm, Roxane, Sandoz, Vintage, Watson Labs, Cenci, Ferndale Labs, Akorn, Bel Mar, Fera Pharms, X Gen Pharms, Genus Lifesciences, Bausch And Lomb, Wockhardt, Glenmark Generics, Taro Pharm Inds, Lupin Ltd, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Intl Medication, and G And W Labs Inc, and is included in one hundred and twenty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the HYDROCORTISONE profile page.

The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are sixty-four 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 040879
Tradename:HYDROCORTISONE
Applicant:Rising Pharms
Ingredient:hydrocortisone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040879
Medical Subject Heading (MeSH) Categories for 040879
Suppliers and Packaging for NDA: 040879
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 040879 ANDA Lyne Laboratories, Inc. 0374-5050 0374-5050-01 144 CARTON in 1 BOX (0374-5050-01) > 1 TUBE in 1 CARTON > 30 g in 1 TUBE
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 040879 ANDA Rising Pharmaceuticals, Inc. 64980-324 64980-324-30 1 TUBE in 1 CARTON (64980-324-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Aug 20, 2010TE:ATRLD:No

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