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Generated: October 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207029

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NDA 207029 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 Pharms, 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, PII, Purepac Pharm, Roxane, Sandoz, Vintage, Watson Labs, Cenci, Ferndale Labs, Akorn, Bel Mar, Fera Pharms, X Gen Pharms, Genus Lifesciences, Bausch And Lomb, Wockhardt, Glenmark Generics, Taro Pharm Inds, Lupin Ltd, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Intl Medication, and G And W Labs Inc, and is included in one hundred and twenty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the HYDROCORTISONE profile page.

The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are sixty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 207029
Tradename:HYDROCORTISONE
Applicant:Pii
Ingredient:hydrocortisone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207029
Medical Subject Heading (MeSH) Categories for 207029
Suppliers and Packaging for NDA: 207029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE hydrocortisone TABLET;ORAL 207029 ANDA Vensun Pharmaceuticals, Inc. 42543-140 42543-140-50 50 TABLET in 1 BOTTLE, PLASTIC (42543-140-50)
HYDROCORTISONE hydrocortisone TABLET;ORAL 207029 ANDA Vensun Pharmaceuticals, Inc. 42543-141 42543-141-01 100 TABLET in 1 BOTTLE, PLASTIC (42543-141-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 27, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 27, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 27, 2017TE:ABRLD:No

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