Home Applications 021158 Application 021158
Type NDA
Sponsor LG CHEM LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FACTIVE GEMIFLOXACIN MESYLATE TABLET;ORAL EQ 320MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021158-001 FACTIVE GEMIFLOXACIN MESYLATE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04
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.
Product history page 2 of 2 · 44 observed 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 2022-10-28 04:53 UTC 2022-10 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021158-001 FACTIVE EQ 320MG BASE TABLET / ORAL RLD 2003-04-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021158-001 FACTIVE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-04-04 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021158-001 6340689 2019-09-14 U-512 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6262071 2019-09-21 U-513 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6331550 2019-09-21 U-511 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6455540 2019-09-21 U-511 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021158-001 6340689 2019-09-14 U-512 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6262071 2019-09-21 U-513 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6331550 2019-09-21 U-511 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6455540 2019-09-21 U-511 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021158-001 6340689 2019-09-14 U-512 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6262071 2019-09-21 U-513 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6331550 2019-09-21 U-511 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6455540 2019-09-21 U-511 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021158-001 6340689 2019-09-14 U-512 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6262071 2019-09-21 U-513 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6331550 2019-09-21 U-511 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6455540 2019-09-21 U-511 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6803376 2019-09-21 U-609 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021158-001 6803376 2019-09-21 U-608 Drug substance, Drug product ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44001-321 FACTIVE gemifloxacin mesylate Merus Labs International Inc. NDA Current 44004-321 FACTIVE gemifloxacin mesylate Vansen Pharma Inc. NDA Current