Home Applications 020189 Application 020189
Type NDA
Sponsor MYLAN SPECIALITY LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FELBATOL FELBAMATE TABLET;ORAL 400MG Yes No 002 FELBATOL FELBAMATE TABLET;ORAL 600MG Yes Yes 003 FELBATOL FELBAMATE SUSPENSION;ORAL 600MG/5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020189-001 FELBATOL FELBAMATE 400MG TABLET / ORAL AB RLD 1993-07-29 N020189-002 FELBATOL FELBAMATE 600MG TABLET / ORAL AB RLD, RS 1993-07-29 N020189-003 FELBATOL FELBAMATE 600MG/5ML SUSPENSION / ORAL RLD 1993-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL RLD 1993-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020189-002 FELBATOL 600MG TABLET / ORAL AB RLD, RS 1993-07-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020189-003 FELBATOL 600MG/5ML SUSPENSION / ORAL AB RLD, RS 1993-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020189-001 FELBATOL 400MG TABLET / ORAL AB RLD 1993-07-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 121 observed states.
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 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0037-0430 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0430 Felbatol felbamate Meda Pharmaceuticals Inc. NDA Current 0037-0430 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0430 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0430 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0431 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0431 Felbatol felbamate Meda Pharmaceuticals Inc. NDA Current 0037-0431 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0431 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0431 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0442 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0442 Felbatol felbamate Meda Pharmaceuticals Inc. NDA Current 0037-0442 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0442 Felbatol felbamate Meda Pharmaceuticals NDA Current 0037-0442 Felbatol felbamate Meda Pharmaceuticals NDA Current 51525-0430 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0430 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0430 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0430 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0431 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0431 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0431 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0431 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0442 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0442 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0442 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 51525-0442 Felbamate felbamate Wallace Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 43641 SUPPL 2012-09-06 12311 SUPPL 2012-09-06 24556 SUPPL 2012-09-05 34356 SUPPL 2011-07-07 24555 SUPPL 2011-07-07 12310 SUPPL 2009-05-13 24554 SUPPL 2009-05-01 24142 ORIG 2008-02-01 2153 SUPPL 2002-11-19