Application 040407

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCHLORPERAZINE	PROCHLORPERAZINE	SUPPOSITORY;RECTAL	2.5MG	No	No
002	PROCHLORPERAZINE	PROCHLORPERAZINE	SUPPOSITORY;RECTAL	5MG	No	No
003	PROCHLORPERAZINE	PROCHLORPERAZINE	SUPPOSITORY;RECTAL	25MG	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
A040407-001	PROCHLORPERAZINE	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11
A040407-002	PROCHLORPERAZINE	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11
A040407-003	PROCHLORPERAZINE	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11

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	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040407-001	PROCHLORPERAZINE	2.5MG	SUPPOSITORY / RECTAL	2001-07-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040407-002	PROCHLORPERAZINE	5MG	SUPPOSITORY / RECTAL	2001-07-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040407-003	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	2001-07-11	`3a93d1ddd44b…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine	PROCHLORPERAZINE	Cosette Pharmaceuticals, Inc.	9595346e-76e5-e155-341b-ffaaafb885ab	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine generic name: PROCHLORPERAZINE
Compro	PROCHLORPERAZINE	PD-Rx Pharmaceuticals, Inc.	b23b67eb-78b7-48eb-84ff-c95d3ce8683c	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE
Compro	PROCHLORPERAZINE	Padagis US LLC	ea381bc5-0957-4c91-826a-0ff680cebacc	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE
Prochlorperazine	PROCHLORPERAZINE	PharmPak, Inc.	383744db-ba57-478a-8041-2ecc26d3e1ec	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine generic name: PROCHLORPERAZINE

Reported adverse events (FAERS/openFDA)#

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