FDAsafety guidance66% confidence
FDA AP — DILTIAZEM HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Baxter Healthcare; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA216327. Sponsor: SCIEGEN PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DILTIAZEM HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Cardiovascular · Vasopressor
- Sub-indication
- General
Related signal: FDA Grants Approval for Phenylephrine Hydrochloride by Baxter Healthcare