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 1.

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
2026-02-19 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
2026-02-19 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 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	9588d223-41e4-4bb2-9306-f082498404c5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	cf41a02d-c881-4b40-b99c-d5b79dbd645b	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	da5519cd-7b96-4468-910c-87dffdb1888e	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	fc903628-248c-4d12-88b4-a551aeadb4d2	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	bb08cedf-18ab-4341-a84e-c092ff7a5c98	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
perphenazine	PERPHENAZINE	REMEDYREPACK INC.	1fc98e41-17d1-4491-87ed-ff7651422b5b	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	1a216d3f-12b0-44c2-b7d3-109fee45978d	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	8028ab47-a6de-4924-a4cd-9336fa90dd90	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Chartwell RX, LLC	ba5f3963-3080-48bc-806a-0aed72e2c25b	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	American Health Packaging	a17c90f9-3d5d-4503-ba2c-754b45decbf8	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	aaa1127a-393d-454a-b68a-b1f206117f3b	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
PERPHENAZINE	PERPHENAZINE	REMEDYREPACK INC.	c4150683-0772-4344-bb1c-f050b84175d6	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PERPHENAZINE generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	f6af1fc3-868d-46f3-8bbe-828375fb0fae	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	e2e52bd9-b9c2-4f04-af03-bdb54b48c16c	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	afaea32d-0dc1-4dcb-9ee2-dd2937ec030e	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	41758282-6848-4a47-bbf3-89edc270f7b3	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Major Pharmaceuticals	0dc77ea9-32ee-4b6d-b69d-8c712bcf5fe4	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
Perphenazine	PERPHENAZINE	Actavis Pharma, Inc.	bb1a3d20-1f93-48a1-9e27-4712a8561757	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Perphenazine generic name: PERPHENAZINE
perphenazine	PERPHENAZINE	Golden State Medical Supply, Inc.	f0ea4d18-643d-7acb-e053-2a95a90a9ea7	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: perphenazine generic name: PERPHENAZINE
PERPHENAZINE	PERPHENAZINE	Rising Pharma Holdings, Inc.	0ebf4c11-1810-42f6-a8e3-071616e33d5d	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PERPHENAZINE generic name: PERPHENAZINE