Application 079019

Type: ANDA
Sponsor: GLENMARK PHARMS 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
A079019-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079019-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079019-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079019-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079019-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079019-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30
A079019-007	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
A079019-001	AB
A079019-002	AB
A079019-003	AB
A079019-004	AB
A079019-005	AB
A079019-006	AB
A079019-007	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	A079019-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-05-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-007	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	A079019-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079019-007	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	97a4aa63-0877-40e5-94c4-ea487db5691d	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079019 application number: ANDA079019
atomoxetine	ATOMOXETINE	A-S Medication Solutions	90f45a1e-f79f-468f-b21b-5dc82f5717aa	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079019 application number: ANDA079019
atomoxetine	ATOMOXETINE	Northstar Rx LLC	133a4b65-762b-4712-baba-2442546f0379	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079019 application number: ANDA079019 ndc (product): 16714-755 ndc (product): 16714-757 ndc (product): 16714-758 ndc (product): 16714-760 ndc (product): 16714-756 ndc (product): 16714-761 ndc (product): 16714-759
atomoxetine	ATOMOXETINE	Glenmark Pharmaceuticals Inc., USA	0ab8d905-e890-4e91-a730-3e5d12f5c23f	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079019 application number: ANDA079019 ndc (product): 68462-270 ndc (product): 68462-269 ndc (product): 68462-268 ndc (product): 68462-266 ndc (product): 68462-271 ndc (product): 68462-267 ndc (product): 68462-265
atomoxetine	ATOMOXETINE	A-S Medication Solutions	f75bc8e2-8e8e-4883-be9c-b716842c5277	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079019 application number: ANDA079019
atomoxetine	ATOMOXETINE	A-S Medication Solutions	793928fb-fbcb-4fc6-90d4-f8a15e6b1f93	2024-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079019 application number: ANDA079019
atomoxetine	ATOMOXETINE	A-S Medication Solutions	47f6faeb-52b5-4b04-bf34-de5db8eb46dc	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079019 application number: ANDA079019

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-755	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-755	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-755	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-755	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-756	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-756	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-756	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-756	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-757	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-757	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-757	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-757	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-758	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-758	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-758	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-758	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-759	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-759	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-759	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-759	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-760	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-760	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-760	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-760	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-761	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-761	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-761	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
16714-761	atomoxetine	atomoxetine	Northstar Rx LLC	ANDA	Current
68462-265	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-265	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-265	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-265	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-265	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-266	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-266	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-266	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-266	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-266	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-267	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-267	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-267	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-267	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-267	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-268	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-268	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-268	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-268	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-268	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-269	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-269	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-269	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-269	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-269	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-270	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-270	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-270	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-270	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-270	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-271	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-271	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-271	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-271	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-271	atomoxetine	atomoxetine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-2474	atomoxetine	atomoxetine	REMEDYREPACK INC.	ANDA	Current
70518-2474	atomoxetine	atomoxetine	REMEDYREPACK INC.	ANDA	Current
70518-2474	atomoxetine	atomoxetine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48631	ORIG	2017-06-02