Application 202682

Type: ANDA
Sponsor: HETERO USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	No	No
002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	18MG	No	No
003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	25MG	No	No
004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	40MG	No	No
005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	60MG	No	No
006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	80MG	No	No
007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202682-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2021-03-11
A202682-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB		2021-03-11
A202682-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		2021-03-11
A202682-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB		2021-03-11
A202682-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	RS	2021-03-11
A202682-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB		2021-03-11
A202682-007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		2021-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A202682-001	AB
A202682-002	AB
A202682-003	AB
A202682-004	AB
A202682-005	AB
A202682-006	AB
A202682-007	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 7 · 245 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	A202682-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2021-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB		2021-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		2021-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB		2021-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	RS	2021-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB		2021-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		2021-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202682-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2021-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB		2021-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		2021-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB		2021-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	RS	2021-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB		2021-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		2021-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2021-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB		2021-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		2021-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB		2021-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	RS	2021-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB		2021-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		2021-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202682-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2021-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB		2021-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		2021-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB		2021-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB		2021-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB		2021-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		2021-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2021-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB		2021-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		2021-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB		2021-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB		2021-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB		2021-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		2021-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2021-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB		2021-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		2021-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB		2021-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB		2021-03-11	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 245 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	A202682-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202682-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202682-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202682-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202682-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202682-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202682-005	AB	1	`b8a1b40f171c…`

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
Atomoxetine	ATOMOXETINE	Camber Pharmaceuticals, Inc.	f266ab7b-5a68-42b5-b204-e3249bea0aed	2026-05-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202682 application number: ANDA202682 ndc (product): 31722-714 ndc (product): 31722-717 ndc (product): 31722-715 ndc (product): 31722-716 ndc (product): 31722-719 ndc (product): 31722-718 ndc (product): 31722-720
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	652cb30f-4368-4009-93a3-3a0d2a365f42	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202682 application number: ANDA202682 ndc (product): 50090-6127
Atomoxetine	ATOMOXETINE	NorthStar RxLLC	14f2804d-2914-4dd9-86c0-d084fcfd7e50	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202682 application number: ANDA202682
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	14fb8a4c-c2bf-4d44-bea9-cd159c2ca5fa	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202682 application number: ANDA202682 ndc (product): 50090-6144
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	0782204e-56a3-4439-9fb8-194da9487049	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202682 application number: ANDA202682 ndc (product): 50090-6143

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-714	Atomoxetine	Atomoxetine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-715	Atomoxetine	Atomoxetine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-716	Atomoxetine	Atomoxetine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-717	Atomoxetine	Atomoxetine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-718	Atomoxetine	Atomoxetine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-719	Atomoxetine	Atomoxetine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-720	Atomoxetine	Atomoxetine	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-6127	Atomoxetine	Atomoxetine	A-S Medication Solutions	ANDA	Current
50090-6143	Atomoxetine	Atomoxetine	A-S Medication Solutions	ANDA	Current
50090-6144	Atomoxetine	Atomoxetine	A-S Medication Solutions	ANDA	Current