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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Julphar
Citi
Daiichi Sankyo
QuintilesIMS
Teva
Dow
Accenture
McKesson

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040646

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NDA 040646 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-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 040646
Tradename:HYDROCORTISONE
Applicant:Impax Labs Inc
Ingredient:hydrocortisone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 040646
Medical Subject Heading (MeSH) Categories for 040646
Suppliers and Packaging for NDA: 040646
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone TABLET;ORAL 040646 ANDA Impax Generics 0115-1696 N 0115-1696-06
HYDROCORTISONE hydrocortisone TABLET;ORAL 040646 ANDA Impax Generics 0115-1697 N 0115-1697-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 30, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 30, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Mar 30, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
Dow
Citi
Daiichi Sankyo
Colorcon
Fuji
Chinese Patent Office
Covington

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