Home Applications 021299 Application 021299
Type NDA
Sponsor SEBELA IRELAND LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PEXEVA PAROXETINE MESYLATE TABLET;ORAL EQ 10MG BASE Yes No 002 PEXEVA PAROXETINE MESYLATE TABLET;ORAL EQ 20MG BASE Yes No 003 PEXEVA PAROXETINE MESYLATE TABLET;ORAL EQ 30MG BASE Yes No 004 PEXEVA PAROXETINE MESYLATE TABLET;ORAL EQ 40MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021299-001 PEXEVA PAROXETINE MESYLATE EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 N021299-002 PEXEVA PAROXETINE MESYLATE EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 N021299-003 PEXEVA PAROXETINE MESYLATE EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 N021299-004 PEXEVA PAROXETINE MESYLATE EQ 40MG BASE TABLET / ORAL RLD 2003-07-03
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 5 · 168 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 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-001 PEXEVA EQ 10MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-002 PEXEVA EQ 20MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-003 PEXEVA EQ 30MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-004 PEXEVA EQ 40MG BASE TABLET / ORAL RLD 2003-07-03 d8e5a09893c0…
Observed Orange Book patent history# Patent history page 1 of 4 · 156 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-001 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-002 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-003 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021299-004 7598271 2025-05-04 Drug substance 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021299-001 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-002 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-003 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021299-004 7598271 2025-05-04 Drug substance 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-001 7598271 2025-05-04 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-002 7598271 2025-05-04 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-003 7598271 2025-05-04 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021299-004 7598271 2025-05-04 Drug substance fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-001 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-002 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-003 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021299-004 7598271 2025-05-04 Drug substance b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-001 7598271 2025-05-04 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-002 7598271 2025-05-04 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-003 7598271 2025-05-04 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021299-004 7598271 2025-05-04 Drug substance 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-001 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-002 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-003 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021299-004 7598271 2025-05-04 Drug substance 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-001 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-002 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-003 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021299-004 7598271 2025-05-04 Drug substance 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-001 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-002 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-003 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021299-004 7598271 2025-05-04 Drug substance d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021299-001 7598271 2025-05-04 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-002 7598271 2025-05-04 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-003 7598271 2025-05-04 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021299-004 7598271 2025-05-04 Drug substance d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-001 7598271 2025-05-04 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-002 7598271 2025-05-04 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-003 7598271 2025-05-04 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021299-004 7598271 2025-05-04 Drug substance 79d66fd596c7…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54766-201 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-201 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-201 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-201 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-201 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-201 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-202 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-202 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-202 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-202 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-202 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-202 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-203 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-203 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-203 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-203 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-203 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-203 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-204 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-204 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-204 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-204 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-204 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current 54766-204 PEXEVA paroxetine mesylate Sebela Pharmaceuticals Inc. NDA Current