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Last Updated: September 22, 2020

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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, 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 087795
Tradename:HYDROCORTISONE
Applicant:Actavis Mid Atlantic
Ingredient:hydrocortisone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087795
Medical Subject Heading (MeSH) Categories for 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 Rising Pharmaceuticals, Inc. 64980-302 64980-302-30 1 TUBE in 1 CARTON (64980-302-30) > 28 g in 1 TUBE

Profile for product number 001

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

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