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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085027

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NDA 085027 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. Seven suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 085027
Tradename:HYDROCORTISONE
Applicant:Perrigo New York
Ingredient:hydrocortisone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 085027
Medical Subject Heading (MeSH) Categories for 085027
Suppliers and Packaging for NDA: 085027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone OINTMENT;TOPICAL 085027 ANDA Perrigo New York Inc 45802-014 N 45802-014-02
HYDROCORTISONE hydrocortisone OINTMENT;TOPICAL 085027 ANDA Perrigo New York Inc 45802-014 N 45802-014-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength2.5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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