Application 089685

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	8MG	No	No
002	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	2MG	No	No
003	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	4MG	No	No
004	PERPHENAZINE	PERPHENAZINE	TABLET;ORAL	16MG	No	Yes

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	RLD / RS	Approval date
A089685-001	PERPHENAZINE	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08
A089685-002	PERPHENAZINE	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08
A089685-003	PERPHENAZINE	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08
A089685-004	PERPHENAZINE	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089685-001	AB
A089685-002	AB
A089685-003	AB
A089685-004	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A089685-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089685-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089685-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-004	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.	9588d223-41e4-4bb2-9306-f082498404c5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	da5519cd-7b96-4468-910c-87dffdb1888e	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	fc903628-248c-4d12-88b4-a551aeadb4d2	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685 ndc (product): 70518-3108
Perphenazine	PERPHENAZINE	Sandoz Inc	fc32500c-cc42-4f85-9cee-88f983fcbc16	2024-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685 ndc (product): 0781-8049 ndc (product): 0781-8047 ndc (product): 0781-8048 ndc (product): 0781-8046

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1046	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-1047	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-1048	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-1049	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8046	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8046	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8046	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8047	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8047	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8047	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8048	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8048	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8048	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8049	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8049	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
0781-8049	Perphenazine	Perphenazine	Sandoz Inc	ANDA	Current
21695-415	Perphenazine	Perphenazine	Rebel Distributors Corp	ANDA	Current
53808-0760	Perphenazine	PERPHENAZINE	State of Florida DOH Central Pharmacy	ANDA	Current
67046-541	Perphenazine	Perphenazine	Contract Pharmacy Services-PA	ANDA	Current
70518-1158	Perphenazine	Perphenazine	REMEDYREPACK INC.	ANDA	Current
70518-1158	Perphenazine	Perphenazine	REMEDYREPACK INC.	ANDA	Current
70518-3108	Perphenazine	Perphenazine	REMEDYREPACK INC.	ANDA	Current
70518-3108	Perphenazine	Perphenazine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18528	SUPPL	2013-12-11