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Deloitte
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Citi
Cantor Fitzgerald
Argus Health
Queensland Health
Medtronic
Julphar
Healthtrust

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040351

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NDA 040351 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 Inc, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, 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, Vintage Pharms, Bausch And Lomb, Wockhardt, Glenmark Generics, Taro Pharm Inds, Teligent Pharma Inc, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Intl Medication, and G And W Labs Inc, and is included in one hundred and twenty-two 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. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 040351
Tradename:HYDROCORTISONE
Applicant:Fougera Pharms
Ingredient:hydrocortisone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 040351
Medical Subject Heading (MeSH) Categories for 040351
Suppliers and Packaging for NDA: 040351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone LOTION;TOPICAL 040351 ANDA E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc. 0168-0288 N 0168-0288-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength2.5%
Approval Date:Jul 25, 2000TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
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Dow
Colorcon
Covington
Medtronic
Mallinckrodt
Argus Health
UBS

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