ZITHROMAX (AZITHROMYCIN DIHYDRATE)
Summary
FDA approved ZITHROMAX (AZITHROMYCIN DIHYDRATE) by PFIZER. NDA (New Drug) approval (Labeling) on 2021-11-22. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA050784-37
Action Date
2021-11-22
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ZITHROMAX (generic: AZITHROMYCIN DIHYDRATE), TABLET, ORAL. Application: NDA050784
Company
Context & Analysis
PFIZER has 28 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
How often does PFIZER have FDA actions?
PFIZER has 28 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA050784-37" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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