APPLICATION
ANDA214531
TYPE
ANDA
ORIGINAL APPROVAL
2021-12-28
LATEST ACTION
2023-05-08
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.042% BASE · SOLUTION · INHALATION
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.021% BASE · SOLUTION · INHALATION
Approval history
2023-05-08Labeling · Supplement 1 · standardAP
2021-12-28UNKNOWN · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.