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Serving 500+ biopharmaceutical companies globally:

McKesson
Covington
Accenture
Healthtrust
Teva
Argus Health
Cerilliant
UBS
Harvard Business School
Merck

Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040879

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NDA 040879 describes HYDROCORTISONE, which is a drug marketed by Teva, Vintage Pharms, Fougera Pharms Inc, Naska, Taro, Pharmaderm, Alpharma Us Pharms, Elkins Sinn, Perrigo New York, Syosset, Usl Pharma, PII, Inwood Labs, Ivax Pharms, Pharmafair, Roxane, Nexgen Pharma Inc, Sandoz, Parke Davis, Whiteworth Town Plsn, Impax Labs Inc, Purepac Pharm, Altana, Fougera Pharms, Everylife, Watson Labs, Ingram Pharm, G And W Labs, Panray, Vintage, Hikma Intl Pharms, Ferrante, Stiefel, Lannett, Ambix, Teva Pharms, Topiderm, Rising Pharms Inc, Impax Labs, Actavis Mid Atlantic, Mericon, Paddock Llc, Barr, Cenci, Fera Pharms, Akorn, Bel Mar, Ferndale Labs, X Gen Pharms, Wockhardt, Bausch And Lomb, 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 NDA: 040879

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

Pharmacology for NDA: 040879

Suppliers and Packaging for NDA: 040879

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE
hydrocortisone
CREAM;TOPICAL 040879 ANDA Lyne Laboratories, Inc. 0374-5050 0374-5050-01 144 CARTON in 1 BOX (0374-5050-01) > 1 TUBE in 1 CARTON > 30 g in 1 TUBE
HYDROCORTISONE
hydrocortisone
CREAM;TOPICAL 040879 ANDA Rising Pharmaceuticals, Inc. 64980-324 64980-324-30 1 TUBE in 1 CARTON (64980-324-30) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Aug 20, 2010TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
Teva
Cerilliant
Colorcon
Medtronic
Boehringer Ingelheim
Daiichi Sankyo
Novartis
US Army
Johnson and Johnson

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