Application 079017

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	18MG	No	No
002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	25MG	No	No
003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	40MG	No	No
004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	60MG	No	No
005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	80MG	No	No
006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	100MG	No	No
007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	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
A079017-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16
A079017-007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079017-001	AB
A079017-002	AB
A079017-003	AB
A079017-004	AB
A079017-005	AB
A079017-006	AB
A079017-007	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 · 276 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	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-006	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2010-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-007	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2023-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-001	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2010-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-002	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2010-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-003	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2010-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-004	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2010-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-005	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2010-09-16	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 276 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	A079017-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079017-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079017-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079017-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079017-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079017-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079017-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079017-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079017-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
atomoxetine	ATOMOXETINE	Zydus Pharmaceuticals USA Inc.	5f89c7c9-4c25-4ba2-ad90-5aeadb48f214	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079017 application number: ANDA079017 ndc (product): 68382-218 ndc (product): 68382-216 ndc (product): 68382-223 ndc (product): 68382-217 ndc (product): 68382-220 ndc (product): 68382-219

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-606	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-606	atomoxetine	atomoxetine	Zydus Lifesciences Limited	ANDA	Current
65841-606	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-606	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-607	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-607	atomoxetine	atomoxetine	Zydus Lifesciences Limited	ANDA	Current
65841-607	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-607	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-608	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-608	atomoxetine	atomoxetine	Zydus Lifesciences Limited	ANDA	Current
65841-608	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-608	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-609	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-609	atomoxetine	atomoxetine	Zydus Lifesciences Limited	ANDA	Current
65841-609	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-609	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-610	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-610	atomoxetine	atomoxetine	Zydus Lifesciences Limited	ANDA	Current
65841-610	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-610	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-611	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-611	atomoxetine	atomoxetine	Zydus Lifesciences Limited	ANDA	Current
65841-611	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
65841-611	atomoxetine	atomoxetine	Cadila Healthcare Limited	ANDA	Current
68382-216	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-216	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-216	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-216	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-217	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-217	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-217	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-217	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-218	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-218	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-218	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-218	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-219	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-219	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-219	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-219	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-220	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-220	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-220	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-220	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-223	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-223	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-223	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-223	atomoxetine	atomoxetine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current