Application 205232

Type: ANDA
Sponsor: ZYDUS PHARMS

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 42.

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
A205232-001	PERPHENAZINE	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06
A205232-002	PERPHENAZINE	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06
A205232-003	PERPHENAZINE	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06
A205232-004	PERPHENAZINE	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205232-001	AB
A205232-002	AB
A205232-003	AB
A205232-004	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.

Product history page 1 of 4 · 152 observed 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	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2020-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2020-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2020-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2020-04-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205232-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205232-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205232-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205232-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205232-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205232-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205232-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205232-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205232-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205232-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205232-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205232-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205232-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205232-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205232-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205232-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205232-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205232-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205232-004	AB	1	`d8e5a09893c0…`

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
perphenazine	PERPHENAZINE	REMEDYREPACK INC.	1fc98e41-17d1-4491-87ed-ff7651422b5b	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205232 application number: ANDA205232 ndc (product): 70518-3257
perphenazine	PERPHENAZINE	Golden State Medical Supply, Inc.	f0ea4d18-643d-7acb-e053-2a95a90a9ea7	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205232 application number: ANDA205232 ndc (product): 51407-697 ndc (product): 51407-696 ndc (product): 51407-694 ndc (product): 51407-695
perphenazine	PERPHENAZINE	Zydus Pharmaceuticals (USA) Inc.	c209f1f6-f440-4366-8140-1d24cf0c2ce6	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205232 application number: ANDA205232 ndc (product): 68382-593 ndc (product): 68382-594 ndc (product): 68382-592 ndc (product): 68382-591
perphenazine	PERPHENAZINE	Zydus Lifesciences Limited	003fe32c-a55d-4191-99fa-1013522b1b2e	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205232 application number: ANDA205232 ndc (product): 70771-1044 ndc (product): 70771-1042 ndc (product): 70771-1043 ndc (product): 70771-1041

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-694	perphenazine	perphenazine	Golden State Medical Supply, Inc.	ANDA	Current
51407-695	perphenazine	perphenazine	Golden State Medical Supply, Inc.	ANDA	Current
51407-696	perphenazine	perphenazine	Golden State Medical Supply, Inc.	ANDA	Current
51407-697	perphenazine	perphenazine	Golden State Medical Supply, Inc.	ANDA	Current
68382-591	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-591	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-592	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-592	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-593	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-593	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-594	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-594	perphenazine	perphenazine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-3033	perphenazine	perphenazine	REMEDYREPACK INC.	ANDA	Current
70518-3121	perphenazine	perphenazine	REMEDYREPACK INC.	ANDA	Current
70518-3121	perphenazine	perphenazine	REMEDYREPACK INC.	ANDA	Current
70518-3257	perphenazine	perphenazine	REMEDYREPACK INC.	ANDA	Current
70771-1041	perphenazine	perphenazine	Cadila Healthcare Limited	ANDA	Current
70771-1042	perphenazine	perphenazine	Cadila Healthcare Limited	ANDA	Current
70771-1043	perphenazine	perphenazine	Cadila Healthcare Limited	ANDA	Current
70771-1044	perphenazine	perphenazine	Cadila Healthcare Limited	ANDA	Current