Drug application
NITHIODOTE (SODIUM NITRITE, SODIUM THIOSULFATE)
Drugs@FDA NDA 201444 · HOPE PHARMS
Key facts
| Drug name | NITHIODOTE |
|---|---|
| Active ingredients | SODIUM NITRITE, SODIUM THIOSULFATE |
| Application type | NDA |
| Application number | 201444 |
| Company | HOPE PHARMS |
| Dosage forms | SOLUTION, SOLUTION, INTRAVENOUS, INTRAVENOUS |
| Strength | 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Jan 14, 2011 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: