DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 088481
» See Plans and Pricing
NDA 088481 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Anima, Lannett Co Inc, Lyne, Wockhardt Bio Ag, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Ani Pharms Inc, ECR, Fera Pharms Llc, Heritage Pharma, 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, Amneal, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Dr Reddys, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc, and is included in eighty-three NDAs. It is available from twenty-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 088481
| Tradename: | DEXAMETHASONE |
| Applicant: | Fera Pharms Llc |
| Ingredient: | dexamethasone |
| Patents: | 0 |
| 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 | Fera Pharmaceuticals, LLC | 48102-045 | 48102-045-01 | 100 TABLET in 1 BOTTLE (48102-045-01) |
| DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088481 | ANDA | Fera Pharmaceuticals, LLC | 48102-046 | 48102-046-01 | 100 TABLET in 1 BOTTLE (48102-046-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Nov 28, 1983 | TE: | BP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Apr 28, 1983 | TE: | BP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.75MG | ||||
| Approval Date: | Apr 28, 1983 | TE: | BP | RLD: | No | ||||
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