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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087795

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NDA 087795 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 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 087795

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 087795

Suppliers and Packaging for NDA: 087795

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 087795 ANDA Actavis Pharma, Inc. 0472-0321 0472-0321-26 1 TUBE in 1 CARTON (0472-0321-26) > 28.4 g in 1 TUBE
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 087795 ANDA STAT Rx USA LLC 16590-121 16590-121-30 1 TUBE in 1 CARTON (16590-121-30) > 28.4 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:May 3, 1983TE:ATRLD:No


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Federal Trade Commission
Fish and Richardson
US Army
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