All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-5876
Request that the FDA declare that the proposed drug product, Levetiracetam Powder for Oral Solution, 250 mg/ sachet, 500 mg/sachet, 750 mg/sachet, 1,000 mg/sachet and 1500 mg/sachet are suitable for submission as an ANDA
Documents
5
Comments
0
Description
OPEN
Key Dates
Comment Period OpensMay 21, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Suitability Petition
Lachman Consulting Services, Inc.
declare that the proposed drug product
Levetiracetam Powder for Oral Solution
250 mg/ sachet, 500 mg/sachet,
750 mg/sachet, 1,000 mg/sachet
1500 mg/sachet are suitable
Data from Regulations.gov