Drugs@FDA document
CODEINE SULFATE Medication Guide · NDA 202245 SUPPL-10
Drugs@FDA document · HIKMA PHARMS · Dec 19, 2023
Key facts
| Drug name | CODEINE SULFATE |
|---|---|
| Document type | Medication Guide |
| Application | NDA202245 |
| Submission | SUPPL-10 |
| Company | HIKMA PHARMS |
| Document date | Dec 19, 2023 |
| FDA document | accessdata.fda.gov |
At a glance
- Labeling-Package Insert Document categories
- 10–99 Documents for this application
- 1–9 USP chapters cited in this application's documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA documents
Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date: