FDAsafety guidance66% confidence
FDA AP — LEVOCETIRIZINE DIHYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for PHARM ASSOC.; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA205564. Sponsor: MACLEODS PHARMS LTD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LEVOCETIRIZINE DIHYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Oncology · Antiemetic
- Sub-indication
- General
Related signal: FDA Submission Update for Ondansetron Hydrochloride (ANDA078127)
Source
FDA document
View source