Application 078983

Type: ANDA
Sponsor: APOTEX

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
A078983-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30
A078983-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30
A078983-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30
A078983-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30
A078983-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30
A078983-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30
A078983-007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078983-001	AB
A078983-002	AB
A078983-003	AB
A078983-004	AB
A078983-005	AB
A078983-006	AB
A078983-007	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 8 · 294 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	A078983-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078983-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078983-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 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	A078983-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078983-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078983-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078983-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078983-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078983-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078983-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078983-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078983-005	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atomoxetine Hydrochloride	ATOMOXETINE HYDROCHLORIDE	Apotex Corp.	132852a6-5bff-15dd-255c-98309dd83630	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983 ndc (product): 60505-2834 ndc (product): 60505-2835 ndc (product): 60505-2836 ndc (product): 60505-2833
Atomoxetine Hydrochloride	ATOMOXETINE HYDROCHLORIDE	AvPAK	9e787cc2-5d0f-f231-e053-2a95a90ae99a	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983
Atomoxetine Hydrochloride	ATOMOXETINE HYDROCHLORIDE	AvPAK	a9df4617-b406-70ba-e053-2995a90a28e8	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983
Atomoxetine Hydrochloride	ATOMOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	6d7ea8f7-981c-4acc-aeaf-7516325bfc0c	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983
Atomoxetine Hydrochloride	ATOMOXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	6f14ced9-c16c-905a-e053-2a91aa0a031e	2025-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983
Atomoxetine Hydrochloride	ATOMOXETINE HYDROCHLORIDE	A-S Medication Solutions	19b10860-aa08-4480-816c-c207819e5f9e	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078983 application number: ANDA078983

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 105 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-2833	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2833	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2833	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2833	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2834	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2834	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2834	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2834	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2834	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2834	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2835	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2835	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2835	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2835	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2835	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2835	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2836	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2836	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2836	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2836	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2836	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
60505-2836	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Apotex Corp.	ANDA	Current
63629-7828	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7828	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7828	Atomoxetine Hydrochloride	atomoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48629	ORIG	2017-06-02