Home Applications 040101 Application 040101
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE No No 002 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 10MG BASE No No 003 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 25MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040101-001 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 A040101-002 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 A040101-003 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19
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 · 126 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 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040101-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-07-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040101-003 PROCHLORPERAZINE MALEATE EQ 25MG BASE TABLET / ORAL 1996-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040101-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-07-19 1e350fbaab3a…
Observed Orange Book normalized TE history# 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.