← FDA DRUG APPROVALS

FDA ANDA · ANDA218089

REVEFENACIN

Sponsor: MANKIND PHARMA LTD

APPLICATION
ANDA218089
TYPE
ANDA
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
None (Tentative Approval)

Products

REVEFENACINNone (Tentative Approval)
REVEFENACIN 175MCG/3ML · SOLUTION · INHALATION

Approval history

2025-01-06UNKNOWN · Original · standardLetterTA
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 →