Details for New Drug Application (NDA): 080399
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NDA 080399 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Chartwell Molecular, Kanchan Hlthcare, Pharmobedient Cnsltg, Rising, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Abraxeolus, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Corepharma, Impax Labs, Key Therap, Larken Labs Inc, Novitium Pharma, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Zydus Lifesciences, Watson Labs Teva, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland Pharma Ltd, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz, and is included in ninety-eight NDAs. It is available from thirty-seven suppliers. Additional details are available on the DEXAMETHASONE profile page.
The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are thirty-nine 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 thirty-nine drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.
Summary for 080399
| Tradename: | DEXAMETHASONE |
| Applicant: | Prasco |
| Ingredient: | dexamethasone |
| Patents: | 0 |
Pharmacology for NDA: 080399
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 080399
Suppliers and Packaging for NDA: 080399
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | dexamethasone | TABLET;ORAL | 080399 | ANDA | A-S Medication Solutions | 50090-6151 | 50090-6151-4 | 6 TABLET in 1 BOTTLE (50090-6151-4) |
| DEXAMETHASONE | dexamethasone | TABLET;ORAL | 080399 | ANDA | A-S Medication Solutions | 50090-6152 | 50090-6152-0 | 28 TABLET in 1 BOTTLE (50090-6152-0) |
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 | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Apr 20, 2022 | TE: | AB | RLD: | No | ||||
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