← FDA DRUG APPROVALS

FDA ANDA · ANDA213657

ALBUTEROL

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA213657
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-14
LATEST ACTION
2020-05-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE · TABLET · ORAL

Approval history

2020-05-14UNKNOWN · Original · standardAP
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 →