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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Cantor Fitzgerald

Generated: March 25, 2018

DrugPatentWatch Database Preview

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, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising Pharms Inc, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Vintage Pharms, 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, 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-eight 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 083365
Applicant:Hikma Intl Pharms
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 083365
Medical Subject Heading (MeSH) Categories for 083365
Suppliers and Packaging for NDA: 083365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone TABLET;ORAL 083365 ANDA West-Ward Pharmaceuticals Corp 0143-1252 N 0143-1252-30
HYDROCORTISONE hydrocortisone TABLET;ORAL 083365 ANDA West-Ward Pharmaceuticals Corp 0143-1252 N 0143-1252-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 23, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 23, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Cantor Fitzgerald
Johnson and Johnson
Chinese Patent Office

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