Application 072691

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMOXAPINE	AMOXAPINE	TABLET;ORAL	150MG	No	Yes
002	AMOXAPINE	AMOXAPINE	TABLET;ORAL	25MG	No	No
003	AMOXAPINE	AMOXAPINE	TABLET;ORAL	50MG	No	No
004	AMOXAPINE	AMOXAPINE	TABLET;ORAL	100MG	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	RLD / RS	Approval date
A072691-001	AMOXAPINE	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28
A072691-002	AMOXAPINE	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28
A072691-003	AMOXAPINE	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28
A072691-004	AMOXAPINE	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072691-001	AB
A072691-002	AB
A072691-003	AB
A072691-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-001	AMOXAPINE	150MG	TABLET / ORAL	AB	RS	1992-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-002	AMOXAPINE	25MG	TABLET / ORAL	AB		1992-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-003	AMOXAPINE	50MG	TABLET / ORAL	AB		1992-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-004	AMOXAPINE	100MG	TABLET / ORAL	AB		1992-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072691-001	AMOXAPINE	150MG	TABLET / ORAL		RS	1992-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072691-002	AMOXAPINE	25MG	TABLET / ORAL			1992-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072691-003	AMOXAPINE	50MG	TABLET / ORAL			1992-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072691-004	AMOXAPINE	100MG	TABLET / ORAL			1992-08-28	`5bbf6a4d5a75…`

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	A072691-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072691-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072691-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072691-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072691-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072691-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072691-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072691-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072691-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072691-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072691-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072691-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072691-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072691-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072691-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072691-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072691-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072691-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072691-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072691-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072691-004	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A072691-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A072691-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A072691-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A072691-004	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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxapine	AMOXAPINE	Actavis Pharma, Inc.	a16297df-3158-48db-85e5-5cd506885556	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072691 application number: ANDA072691 ndc (product): 0591-5715 ndc (product): 0591-5716 ndc (product): 0591-5713 ndc (product): 0591-5714

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5713	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current
0591-5713	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current
0591-5714	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current
0591-5714	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current
0591-5715	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current
0591-5715	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current
0591-5716	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current
0591-5716	Amoxapine	Amoxapine	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18350	SUPPL	2014-09-05