Application 079021

Type: ANDA
Sponsor: MYLAN PHARMS 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	Approval date
A079021-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18
A079021-007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079021-001	AB
A079021-002	AB
A079021-003	AB
A079021-004	AB
A079021-005	AB
A079021-006	AB
A079021-007	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A079021-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079021-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079021-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079021-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079021-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079021-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079021-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079021-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079021-005	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	47cd1d85-fbc1-4309-9365-58bacf108f5b	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	b00eb367-d7cc-42fa-91af-a1a5f90dbb41	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	bb2c12e4-563c-417e-bee1-6d8c51e75af4	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	c5e9e305-8d99-4234-b531-6ade177768b7	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	1d26aff3-72a7-4a5b-a6fe-44dc8a08b196	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	9c1f858c-8721-49e3-be8b-bf180e89ff42	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	bbb2a8f6-0816-47b1-830a-ef23e97d498f	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	c6542d69-d0a2-4663-9172-943f9f6f5325	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021
Atomoxetine	ATOMOXETINE	Strides Pharma Science Limited	2614df7e-0b16-4b03-883e-141d4ec34b35	2025-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079021 application number: ANDA079021