Hospira

RegulatoryJune 9, 2026

FDA Approval Status Update for Lidocaine Hydrochloride 0.4% in Dextrose 5%

The FDA has granted an approval status (AP) for ANDA083158, a supplemental application for Lidocaine Hydrochloride 0.4% in Dextrose 5% submitted by Hospira.

Sponsor company

Mechanism of action

Recent signals(12)

FDA grants supplemental approval for PRECEDEX (dexmedetomidine hydrochloride)

FDA Approves Supplement for Cytarabine by Hospira

FDA Approves Supplement for NYVEPRIA (PEGFILGRASTIM-APGF)

Hospira's Heparin Sodium ANDA090571 Receives AP Status from FDA

FDA Grants AP Status for Heparin Sodium ANDA088100 from Hospira

FDA Grants AP Status for Hospira's Heparin Sodium Preservative Free

FDA Accepts Supplement for PRECEDEX (Dexmedetomidine Hydrochloride)

FDA Grants AP Status for Sufentanil Citrate ANDA074534 by Hospira

FDA Grants AP Status for Lidocaine Hydrochloride ANDA040078

FDA Approves Linezolid in Sodium Chloride 0.9% for Hospira

FDA Grants AP Status for Lidocaine Hydrochloride 0.4% in Dextrose 5%

FDA Approval Status Update for Lidocaine Hydrochloride 0.4% in Dextrose 5%

Upcoming milestones

Related catalysts(9)

Pfizer — Hospira

Pfizer — Hospira

Pfizer — Hospira

Pfizer — Hospira

Pfizer — Hospira

Pfizer — Hospira

Pfizer — Hospira

Pfizer — Hospira

Pfizer — Hospira

Indications

Therapeutic areas

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