APPLICATION
NDA212641
TYPE
NDA
ROUTE
BUCCAL
DOSAGE FORM
FILM
MARKETING STATUS
None (Tentative Approval)
Products
LIBERVANTNone (Tentative Approval)
DIAZEPAM 20MG · FILM · BUCCAL
LIBERVANTNone (Tentative Approval)
DIAZEPAM 15MG · FILM · BUCCAL
LIBERVANTNone (Tentative Approval)
DIAZEPAM 10MG · FILM · BUCCAL
LIBERVANTNone (Tentative Approval)
DIAZEPAM 5MG · FILM · BUCCAL
LIBERVANTNone (Tentative Approval)
DIAZEPAM 17.5MG · FILM · BUCCAL
LIBERVANTNone (Tentative Approval)
DIAZEPAM 12.5MG · FILM · BUCCAL
LIBERVANTNone (Tentative Approval)
DIAZEPAM 7.5MG · FILM · BUCCAL
Approval history
2022-08-30Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Letter ↗TA
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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