Application 213694

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	2MG	No	No
002	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	4MG	No	No
003	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	8MG	No	No
004	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	16MG	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	Approval date
A213694-001	PERPHENAZINE	PERPHENAZINE	2MG	TABLET / ORAL	AB	2025-03-18
A213694-002	PERPHENAZINE	PERPHENAZINE	4MG	TABLET / ORAL	AB	2025-03-18
A213694-003	PERPHENAZINE	PERPHENAZINE	8MG	TABLET / ORAL	AB	2025-03-18
A213694-004	PERPHENAZINE	PERPHENAZINE	16MG	TABLET / ORAL	AB	2025-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A213694-001	AB
A213694-002	AB
A213694-003	AB
A213694-004	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
2026-09-14 22:38:34	2026-08	A213694-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2025-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213694-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2025-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213694-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2025-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213694-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2025-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213694-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2025-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213694-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2025-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213694-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2025-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213694-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2025-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213694-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2025-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213694-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2025-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213694-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2025-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213694-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2025-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2025-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2025-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2025-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2025-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213694-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2025-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213694-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2025-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213694-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2025-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213694-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2025-03-18	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2025-03-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2025-03-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2025-03-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2025-03-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213694-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213694-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213694-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213694-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213694-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213694-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213694-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213694-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213694-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213694-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213694-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213694-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213694-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213694-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213694-004	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213694-004	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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
perphenazine	PERPHENAZINE	Zydus Pharmaceuticals (USA) Inc.	c209f1f6-f440-4366-8140-1d24cf0c2ce6	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: perphenazine generic name: PERPHENAZINE
perphenazine	PERPHENAZINE	Zydus Lifesciences Limited	003fe32c-a55d-4191-99fa-1013522b1b2e	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Wilshire Pharmaceuticals, Inc.	5e455842-4892-4795-8c9b-4109a8f30783	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Macleods Pharmaceuticals Limited	28f0cc81-538c-4a4b-be8d-509428fcbb9c	2024-10-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Sandoz Inc	fc32500c-cc42-4f85-9cee-88f983fcbc16	2024-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	c644628a-76c2-40d9-b7d8-0077743713b9	2023-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	0e87e78e-d39c-44fc-95a0-70cdb2a91941	2023-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	e2f9903c-cbac-4f14-b684-f12cc7e5aa85	2023-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	18c20201-ad92-40ac-8f99-6048c2d32c68	2023-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	9ad131c1-0620-4d3c-9734-bcffd98430e2	2023-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	63e3a25b-a9e2-449d-8631-41f700f4cdeb	2023-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	4882ec28-f516-4dc8-ab15-76cf455af709	2023-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	59b1a63e-6cba-4102-a5e8-83dca540341d	2023-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	b5f08bc9-79b5-4c6f-8fe4-ec2ef022ebe0	2023-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
PERPHENAZINE	PERPHENAZINE	Proficient Rx LP	96322bdc-2183-413b-b7d4-c7192ba7666c	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PERPHENAZINE generic name: PERPHENAZINE

Reported adverse events (FAERS/openFDA)#

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