Application 214534

Type: ANDA
Sponsor: CEROVENE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	1MG	No	No
002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	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
A214534-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07
A214534-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07
A214534-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07
A214534-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214534-001	AB
A214534-002	AB
A214534-003	AB
A214534-004	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 · 144 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	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A214534-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214534-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214534-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214534-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214534-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214534-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-004	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	American Health Packaging	b6eadd59-a7d0-400e-ba1d-795b9243f77d	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	c2c6d6a1-b4b9-506d-e053-2995a90aac23	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534 ndc (product): 51407-458 ndc (product): 51407-461 ndc (product): 51407-459 ndc (product): 51407-460
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	AvPAK	e3277017-1d58-7105-e053-2995a90a9255	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534 ndc (product): 50268-367 ndc (product): 50268-368 ndc (product): 50268-366
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	AvPAK	dbfd138a-e107-3f78-e053-2995a90a6d8c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534 ndc (product): 50268-369
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	98aeddfd-4f24-4d1a-820d-d0abc1733794	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534 ndc (product): 43598-034 ndc (product): 43598-035 ndc (product): 43598-037 ndc (product): 43598-036

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-034	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
43598-034	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
43598-035	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
43598-035	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
43598-036	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
43598-036	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
43598-037	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
43598-037	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Dr. Reddy	ANDA	Current
50268-366	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvPAK	ANDA	Current
50268-367	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvPAK	ANDA	Current
50268-368	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvPAK	ANDA	Current
50268-369	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvPAK	ANDA	Current
50268-369	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvPAK	ANDA	Current
51407-458	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-458	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-459	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-459	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-460	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-460	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-461	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-461	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current