Details for New Drug Application (NDA): 087534
NDA 087534 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Chartwell Molecular, Pharmazone, Pharmobedient Cnsltg, Rising, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Impax Labs, Key Therap, Novitium Pharma, Pangea, Pharmobedient, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Solgen, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Zydus Lifesciences, Watson Labs Teva, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Gland, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Quagen, Somerset, Somerset Theraps Llc, Teva Parenteral, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb Inc, and Caplin, and is included in ninety-two NDAs. It is available from forty suppliers. Additional details are available on the DEXAMETHASONE profile page.
The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are three drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.
The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are three drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.
Summary for 087534
| Tradename: | DEXAMETHASONE |
| Applicant: | Upsher Smith |
| Ingredient: | dexamethasone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 087534
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.75MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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