Application 217847

Type: ANDA
Sponsor: DR REDDYS LABS SA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217847-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		2025-05-19
A217847-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB		2025-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217847-001	AB
A217847-002	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217847-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2025-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217847-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2025-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217847-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2025-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217847-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2025-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217847-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2025-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217847-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2025-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217847-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2025-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217847-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2025-05-19	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217847-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2025-05-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217847-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2025-05-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217847-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217847-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217847-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217847-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217847-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217847-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217847-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217847-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217847-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217847-002	AB	1	`a50c72e98297…`

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Major Pharmaceuticals	d6fc83ad-9cce-4e60-854c-3825313ee60c	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Sportpharm LLC	3d28dab2-0264-482e-b99d-f56a9314b8a5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	ANI Pharmaceuticals, Inc.	50ce4381-94ef-49ff-8794-cfde0ee803b4	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	fc77a504-4642-47c1-b2e3-c5db11e5816d	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
prochlorperazine maleate	PROCHLORPERAZINE MALEATE	Amneal Pharmaceuticals NY LLC	a2a48790-0634-4b46-b362-98b7c252836f	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: prochlorperazine maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	8b58b63c-0a75-406b-bb29-acf0a40353bd	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	GLENMARK PHARMACEUTICALS INC., USA	9c806152-70d0-43eb-b183-b51b12b82b31	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	115a4125-07df-9f9b-e063-6394a90a3e49	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	f2f12ccc-6e51-0a67-e053-2995a90a22bc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	44f278eb-3588-af83-e063-6394a90a73cf	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	QPharma, Inc.	dc692e77-5240-4aa6-8fe9-9ffcbb267261	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	3b022837-0fcc-d38a-e063-6394a90a0f7f	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Jubilant Cadista Pharmaceuticals Inc.	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Cardinal Health 107, LLC	45f56f93-50a7-4cd3-bce2-f97a80556651	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	f387b07a-2d99-4fd5-bcd1-8f04e69b8a39	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	3dd03606-1f58-43ac-e063-6294a90a4439	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Ajanta Pharma USA Inc.	9ab78746-b302-4836-95f3-343799929c0e	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE