Home Applications 213500 Application 213500
Type ANDA
Sponsor CROSSMEDIKA SA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE CAPSULE;ORAL 150MG No No 002 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE CAPSULE;ORAL 200MG No No 003 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE CAPSULE;ORAL 250MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A213500-001 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 A213500-002 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 A213500-003 MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22
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.
Product history page 1 of 3 · 114 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 2026-08-18 06:07:40 2026-07 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213500-002 MEXILETINE HYDROCHLORIDE 200MG CAPSULE / ORAL AB 2020-07-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213500-003 MEXILETINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213500-001 MEXILETINE HYDROCHLORIDE 150MG CAPSULE / ORAL AB 2020-07-22 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Observed Orange Book exclusivity 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-4107 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4107 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4107 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4108 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4108 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4108 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4109 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4109 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 0527-4109 Mexiletine Hydrochloride Mexiletine Hydrochloride Lannett Company, Inc. ANDA Current 10135-730 Mexiletine Hydrochloride Mexiletine Hydrochloride Marlex Pharmaceuticals, Inc. ANDA Current 10135-731 Mexiletine Hydrochloride Mexiletine Hydrochloride Marlex Pharmaceuticals, Inc. ANDA Current 10135-732 Mexiletine Hydrochloride Mexiletine Hydrochloride Marlex Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 64389 ORIG 2020-08-24