← FDA DRUG APPROVALS

FDA ANDA · ANDA085689

PHENTERMINE HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA085689
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-28
LATEST ACTION
1982-05-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PHENTERMINE HYDROCHLORIDEDiscontinued
PHENTERMINE HYDROCHLORIDE 8MG · TABLET · ORAL

Approval history

1982-05-24Manufacturing (CMC) · Supplement 1AP
1982-05-24Manufacturing (CMC) · Supplement 2AP
1978-04-28OriginalAP
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 →