Application 079016

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 1.

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
A079016-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079016-007	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
A079016-001	AB
A079016-002	AB
A079016-003	AB
A079016-004	AB
A079016-005	AB
A079016-006	AB
A079016-007	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A079016-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A079016-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079016-007	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atomoxetine	ATOMOXETINE	American Health Packaging	10d36b32-0202-4c03-8a1a-cd5d53f231e7	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	35b42f0c-a183-478b-bced-652dc12b33ec	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	Aurobindo Pharma Limited	6f6bea0c-297b-43ff-8960-ecc11243e06e	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016 ndc (product): 65862-243 ndc (product): 65862-242 ndc (product): 65862-241 ndc (product): 65862-244
Atomoxetine	ATOMOXETINE	Rising Pharma Holdings, Inc.	1cceab35-dc4a-40bc-a245-10b64820e217	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	50a20478-5f33-4ecd-b5d3-dbba855e5f6b	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	d4fe9217-1853-4f8b-9a93-77e511554ca1	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016 ndc (product): 71335-2162
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	24bb7238-7e12-48d1-a572-2c753e69f604	2023-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016
Atomoxetine	ATOMOXETINE	A-S Medication Solutions	ffdcc267-d6ae-41ee-97d9-2c7596545ce8	2023-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079016 application number: ANDA079016

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 100 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65862-241	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-241	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-241	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-241	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-242	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-242	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-242	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-242	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-242	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-243	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-243	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-243	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-243	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-243	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-244	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-244	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-244	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-244	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
65862-244	Atomoxetine	Atomoxetine	Aurobindo Pharma Limited	ANDA	Current
71335-2162	Atomoxetine	Atomoxetine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48640	ORIG	2017-06-05
48632	ORIG	2017-06-02