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Boehringer Ingelheim
Harvard Business School

Last Updated: September 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089682

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NDA 089682 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, Lannett Co Inc, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Teva, Topiderm, Usl Pharma, 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, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Vintage, Watson Labs, Cenci, Imperium, Akorn, Bel Mar, Fera Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette, Wockhardt, Glenmark Generics, Taro Pharm Inds, Lupin Ltd, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Glenmark Pharms Ltd, and Perrigo Israel, and is included in one hundred and twenty-nine NDAs. It is available from twenty-three suppliers. Additional details are available on the HYDROCORTISONE profile page.

The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are sixty-seven 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 089682
Applicant:Actavis Mid Atlantic
Formulation / Manufacturing:see details
Pharmacology for NDA: 089682
Medical Subject Heading (MeSH) Categories for 089682
Suppliers and Packaging for NDA: 089682
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 089682 ANDA Actavis Pharma, Inc. 0472-0337 0472-0337-20 1 TUBE in 1 CARTON (0472-0337-20) > 20 g in 1 TUBE
HYDROCORTISONE hydrocortisone CREAM;TOPICAL 089682 ANDA Actavis Pharma, Inc. 0472-0337 0472-0337-30 1 TUBE in 1 CARTON (0472-0337-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%
Approval Date:Mar 10, 1988TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim

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