Details for New Drug Application (NDA): 211050
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NDA 211050 describes DIAZOXIDE, which is a drug marketed by Abraxis Pharm, E5 Pharma Inc, and Novitium Pharma, and is included in three NDAs. It is available from two suppliers. Additional details are available on the DIAZOXIDE profile page.
The generic ingredient in DIAZOXIDE is diazoxide. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the diazoxide profile page.
The generic ingredient in DIAZOXIDE is diazoxide. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the diazoxide profile page.
Summary for 211050
| Tradename: | DIAZOXIDE |
| Applicant: | E5 Pharma Inc |
| Ingredient: | diazoxide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 211050
Suppliers and Packaging for NDA: 211050
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIAZOXIDE | diazoxide | SUSPENSION;ORAL | 211050 | ANDA | e5 Pharma, LLC | 13517-100 | 13517-100-30 | 1 BOTTLE, DROPPER in 1 CARTON (13517-100-30) / 30 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 50MG/ML | ||||
| Approval Date: | Dec 20, 2019 | TE: | AB | RLD: | No | ||||
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