DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 088481
NDA 088481 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Lyne, Sti Pharma Llc, Vintage Pharms, Wockhardt Bio Ag, Abraxis Pharm, Fresenius Kabi Usa, West-ward Pharms Int, Watson Labs, ECR, Fera Pharms Llc, Idt Australia Ltd, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Watson Labs Teva, Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Teva Parenteral, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc, and is included in seventy-eight NDAs. It is available from thirty-two 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 088481
| Tradename: | DEXAMETHASONE |
| Applicant: | Fera Pharms Llc |
| Ingredient: | dexamethasone |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) Inflammatory Bowel Disease Agents Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088481
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088481
Suppliers and Packaging for NDA: 088481
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088481 | ANDA | Par Pharmaceutical Inc. | 49884-373 | N | 49884-373-01 |
| DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088481 | ANDA | Pragma Pharmaceuticals, LLC | 58463-017 | N | 58463-017-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Nov 28, 1983 | TE: | BP | RLD: | No | ||||
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