Home Applications 218364 Application 218364
Type ANDA
Sponsor MYLAN LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 500MG/100ML (5MG/ML) No No 002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) No No 003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE;INTRAVENOUS 1.5GM/100ML (15MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218364-001 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 A218364-002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 A218364-003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A218364-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218364-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218364-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218364-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218364-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218364-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218364-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218364-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218364-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2026-05-08 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 9 of 9 · 161 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.