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Serving leading biopharmaceutical companies globally:

Moodys
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QuintilesIMS
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088799

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NDA 088799 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, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Intl Medication, and G And W Labs Inc, and is included in one hundred and twenty NDAs. It is available from thirty-nine 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 088799
Tradename:HYDROCORTISONE
Applicant:Taro
Ingredient:hydrocortisone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 088799
Medical Subject Heading (MeSH) Categories for 088799
Suppliers and Packaging for NDA: 088799
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 088799 ANDA Ranbaxy Laboratories Inc 10631-407 10631-407-01 1 TUBE in 1 CARTON (10631-407-01) > 28.35 g in 1 TUBE
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 088799 ANDA Aidarex Pharmaceuticals LLC 33261-520 33261-520-01 1 TUBE in 1 CARTON (33261-520-01) > 28.35 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Nov 9, 1984TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
US Department of Justice
Express Scripts
McKinsey
Argus Health
Moodys
Fuji
Cipla

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