Details for New Drug Application (NDA): 216282
NDA 216282 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 216282
| Tradename: | DEXAMETHASONE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | dexamethasone |
| Patents: | 0 |
Pharmacology for NDA: 216282
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 216282
Suppliers and Packaging for NDA: 216282
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | dexamethasone | TABLET;ORAL | 216282 | ANDA | Preferred Pharmaceuticals Inc | 68788-4113 | 68788-4113-1 | 12 TABLET in 1 BOTTLE (68788-4113-1) |
| DEXAMETHASONE | dexamethasone | TABLET;ORAL | 216282 | ANDA | Preferred Pharmaceuticals Inc | 68788-4113 | 68788-4113-3 | 30 TABLET in 1 BOTTLE (68788-4113-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Feb 7, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.75MG | ||||
| Approval Date: | Feb 7, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Feb 7, 2024 | TE: | AB | RLD: | No | ||||
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