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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081203

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NDA 081203 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: 081203

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

Pharmacology for NDA: 081203

Suppliers and Packaging for NDA: 081203

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE
hydrocortisone
OINTMENT;TOPICAL 081203 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0146 0168-0146-16 454 g in 1 JAR (0168-0146-16)
HYDROCORTISONE
hydrocortisone
OINTMENT;TOPICAL 081203 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0146 0168-0146-30 29 g in 1 TUBE (0168-0146-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength2.5%
Approval Date:May 28, 1993TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

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