← FDA DRUG APPROVALS

FDA ANDA · ANDA202577

FENTANYL

Sponsor: MYLAN PHARMS INC

APPLICATION
ANDA202577
TYPE
ANDA
ROUTE
BUCCAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

FENTANYLNone (Tentative Approval)
FENTANYL 400MCG · TABLET · BUCCAL
FENTANYLNone (Tentative Approval)
FENTANYL 200MCG · TABLET · BUCCAL
FENTANYLNone (Tentative Approval)
FENTANYL 600MCG · TABLET · BUCCAL
FENTANYLNone (Tentative Approval)
FENTANYL 300MCG · TABLET · BUCCAL
FENTANYLNone (Tentative Approval)
FENTANYL 100MCG · TABLET · BUCCAL
FENTANYLNone (Tentative Approval)
FENTANYL 800MCG · TABLET · BUCCAL

Approval history

2015-03-04UNKNOWN · OriginalLetterTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →