← FDA DRUG APPROVALS

FDA ANDA · ANDA091273

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA091273
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-16
LATEST ACTION
2020-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 850MG, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL

Approval history

2020-02-24Labeling · Supplement 10 · standardAP
2020-02-24Labeling · Supplement 8 · standardAP
2016-10-20Labeling · Supplement 4 · standardAP
2013-04-16OriginalAP
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 →