Home Applications 213932 Application 213932
Type ANDA
Sponsor SUN PHARM INDS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE CAPSULE;ORAL EQ 1.5MG BASE No No 002 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE CAPSULE;ORAL EQ 3MG BASE No No 003 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE CAPSULE;ORAL EQ 4.5MG BASE No No 004 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A213932-001 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL 2022-09-30 A213932-002 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL 2022-09-30 A213932-003 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL 2022-09-30 A213932-004 CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL 2022-09-30
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 3 of 3 · 112 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 2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL 2022-09-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL 2022-09-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL 2022-09-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL 2022-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL 2022-09-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL 2022-09-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL 2022-09-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL 2022-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL 2022-09-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL 2022-09-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL 2022-09-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL 2022-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL 2022-09-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL 2022-09-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL 2022-09-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL 2022-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL 2022-09-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL 2022-09-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL 2022-09-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL 2022-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL AB 2022-09-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL AB 2022-09-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL AB 2022-09-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2022-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL AB 2022-09-30 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL AB 2022-09-30 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL AB 2022-09-30 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL AB 2022-09-30 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213932-001 CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE / ORAL 2022-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213932-002 CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE / ORAL 2022-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213932-003 CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE / ORAL 2022-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213932-004 CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE / ORAL 2022-09-30 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 71763 ORIG 2022-08-09