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 44.

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	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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		1996-07-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1996-07-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		1996-07-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1996-07-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		1996-07-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1996-07-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040101-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040101-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040101-003	PROCHLORPERAZINE MALEATE	EQ 25MG BASE	TABLET / ORAL			1996-07-19	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040101-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040101-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040101-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040101-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040101-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040101-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040101-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040101-002	AB	1	`ea99ee380514…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Chartwell RX, LLC	91adec24-fac8-4a56-b2c3-ae4bbc1160bf	2024-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040101 application number: ANDA040101

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.