METHADOSE (METHADONE HYDROCHLORIDE)
Summary
FDA approved METHADOSE (METHADONE HYDROCHLORIDE) by SPECGX LLC. NDA (New Drug) approval (Labeling) on 2025-12-22. CONCENTRATE, ORAL.
Details
Source
Drug Approval
External ID
NDA017116-48
Action Date
2025-12-22
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
METHADOSE (generic: METHADONE HYDROCHLORIDE), CONCENTRATE, ORAL. Application: NDA017116
Company
Context & Analysis
SPECGX LLC has 19 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
How often does SPECGX LLC have FDA actions?
SPECGX LLC has 19 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 "NDA017116-48" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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