FENTANYL CITRATE
Summary
FDA approved FENTANYL CITRATE by SPECGX LLC. ANDA (Generic) approval (REMS) on 2022-12-08. TROCHE/LOZENGE, TRANSMUCOSAL.
Details
Source
Drug Approval
External ID
ANDA078907-25
Action Date
2022-12-08
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
FENTANYL CITRATE, TROCHE/LOZENGE, TRANSMUCOSAL. Application: ANDA078907
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 "ANDA078907-25" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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