Home Applications 202683 Application 202683
Type ANDA
Sponsor ORCHID HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 2MG No No 002 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 5MG No No 003 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 10MG No No 004 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 15MG No No 005 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 20MG No No 006 ARIPIPRAZOLE ARIPIPRAZOLE TABLET;ORAL 30MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202683-001 ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 A202683-002 ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 A202683-003 ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 A202683-004 ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 A202683-005 ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-05-23 A202683-006 ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 · 258 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 2026-09-14 22:38:34 2026-08 A202683-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202683-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202683-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202683-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202683-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202683-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-05-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202683-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202683-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202683-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202683-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202683-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202683-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202683-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202683-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202683-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202683-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202683-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202683-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202683-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202683-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202683-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202683-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202683-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202683-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202683-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202683-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202683-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202683-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202683-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202683-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202683-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202683-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202683-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202683-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202683-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202683-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202683-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202683-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202683-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202683-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-05-23 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 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 7 of 7 · 121 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.