Home Applications 202768 Application 202768
Type ANDA
Sponsor NATCO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARMODAFINIL ARMODAFINIL TABLET;ORAL 50MG No No 002 ARMODAFINIL ARMODAFINIL TABLET;ORAL 150MG No No 003 ARMODAFINIL ARMODAFINIL TABLET;ORAL 250MG No No 004 ARMODAFINIL ARMODAFINIL TABLET;ORAL 100MG No No 005 ARMODAFINIL ARMODAFINIL TABLET;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202768-001 ARMODAFINIL ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 A202768-002 ARMODAFINIL ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 A202768-003 ARMODAFINIL ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 A202768-004 ARMODAFINIL ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 A202768-005 ARMODAFINIL ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 210 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 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202768-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202768-002 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202768-003 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202768-004 ARMODAFINIL 100MG TABLET / ORAL AB 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202768-005 ARMODAFINIL 200MG TABLET / ORAL AB 2017-09-28 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51991-322 Armodafinil Armodafinil Breckenridge Pharmaceutical, Inc. ANDA Current 51991-323 Armodafinil Armodafinil Breckenridge Pharmaceutical, Inc. ANDA Current 51991-324 Armodafinil Armodafinil Breckenridge Pharmaceutical, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 10104 ORIG 2014-10-21