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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040351

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NDA 040351 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 forty 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: 040351

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

Pharmacology for NDA: 040351

Suppliers and Packaging for NDA: 040351

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE
hydrocortisone
LOTION;TOPICAL 040351 ANDA E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc. 0168-0288 0168-0288-02 59 mL in 1 BOTTLE (0168-0288-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength2.5%
Approval Date:Jul 25, 2000TE:ATRLD:No


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