Application 021411

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	5MG	No	No
002	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	Yes	No
003	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	18MG	Yes	No
004	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	25MG	Yes	No
005	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	40MG	Yes	No
006	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	60MG	Yes	Yes
007	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	80MG	Yes	No
008	STRATTERA	ATOMOXETINE HYDROCHLORIDE	CAPSULE;ORAL	100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021411-001	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		2002-11-26
N021411-002	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-003	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-004	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-005	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-006	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-007	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2005-02-14
N021411-008	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2005-02-14

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 9 · 336 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021411-001	STRATTERA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			2002-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021411-002	STRATTERA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2002-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021411-003	STRATTERA	EQ 18MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2002-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021411-004	STRATTERA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2002-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021411-005	STRATTERA	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2002-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021411-006	STRATTERA	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2002-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021411-007	STRATTERA	EQ 80MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2005-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021411-008	STRATTERA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2005-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021411-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-007	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-006	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-007	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-008	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-006	AB	1	`5bbf6a4d5a75…`

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
Strattera	ATOMOXETINE HYDROCHLORIDE	Eli Lilly and Company	309de576-c318-404a-bc15-660c2b1876fb	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021411 application number: NDA021411 ndc (product): 0002-3238 ndc (product): 0002-3251 ndc (product): 0002-3239 ndc (product): 0002-3229 ndc (product): 0002-3228 ndc (product): 0002-3250 ndc (product): 0002-3227

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 62 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-3227	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3227	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3227	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3227	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3228	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3228	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3228	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3228	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3229	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3229	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3229	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3229	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3238	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3238	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3238	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3238	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3239	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3239	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3239	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3239	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3250	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3250	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3250	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3250	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3251	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3251	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3251	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3251	Strattera	Atomoxetine hydrochloride	Eli Lilly and Company	NDA	Current
49999-636	Strattera	Atomoxetine	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
64725-3228	Strattera	Atomoxetine hydrochloride	TYA Pharmaceuticals	NDA	Current
66993-040	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-040	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-040	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-040	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-041	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-041	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-041	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-042	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-042	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-042	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-042	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-043	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-043	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-043	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-043	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-044	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-044	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-044	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-044	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-045	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-045	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-045	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-045	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-046	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-046	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-046	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-046	Atomoxetine	Atomoxetine hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
68151-4484	Strattera	Atomoxetine hydrochloride	Carilion Materials Management	NDA	Current
68151-4485	Strattera	Atomoxetine hydrochloride	Carilion Materials Management	NDA	Current
68151-4486	Strattera	Atomoxetine hydrochloride	Carilion Materials Management	NDA	Current
68151-4487	Strattera	Atomoxetine hydrochloride	Carilion Materials Management	NDA	Current
68151-4488	Strattera	Atomoxetine hydrochloride	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69821	SUPPL	2022-01-07
69820	SUPPL	2022-01-07
69819	SUPPL	2022-01-07
61971	SUPPL	2020-02-26
61970	SUPPL	2020-02-26
61960	SUPPL	2020-02-26
48504	SUPPL	2017-05-24
48486	SUPPL	2017-05-22
48485	SUPPL	2017-05-22
15411	SUPPL	2015-05-29
27717	SUPPL	2015-05-28
15412	SUPPL	2015-04-21
5304	SUPPL	2015-04-20
27716	SUPPL	2014-02-21
15409	SUPPL	2014-02-21
5303	SUPPL	2013-12-09
15410	SUPPL	2013-12-05
27715	SUPPL	2013-08-06
5302	SUPPL	2013-08-06
15408	SUPPL	2013-08-05
15407	SUPPL	2013-08-05
36860	SUPPL	2012-09-12
27714	SUPPL	2012-08-20
15404	SUPPL	2012-07-10
5299	SUPPL	2012-07-09
15406	SUPPL	2012-06-18
5301	SUPPL	2012-06-18
5300	SUPPL	2011-03-10
15405	SUPPL	2011-03-07
15403	SUPPL	2010-07-31
27713	SUPPL	2010-07-30
27712	SUPPL	2009-06-16
27711	SUPPL	2009-06-16
36859	SUPPL	2009-06-04
15402	SUPPL	2009-06-04
36858	SUPPL	2008-07-29
36857	SUPPL	2008-07-29
15401	SUPPL	2008-07-29
27710	SUPPL	2008-07-25
5298	SUPPL	2008-07-25
5297	SUPPL	2008-07-25
44642	SUPPL	2008-07-17
5292	SUPPL	2008-05-09
36856	SUPPL	2007-10-04
5295	SUPPL	2007-10-04
21642	SUPPL	2007-07-06
36855	SUPPL	2007-05-01
36854	SUPPL	2007-05-01
36853	SUPPL	2007-05-01
36852	SUPPL	2007-05-01
27707	SUPPL	2007-05-01
27703	SUPPL	2007-05-01
15400	SUPPL	2007-05-01
5296	SUPPL	2007-05-01
5294	SUPPL	2007-05-01
5293	SUPPL	2007-05-01
27709	SUPPL	2006-10-23
15399	SUPPL	2006-10-23
27708	SUPPL	2005-11-18
23656	ORIG	2005-09-30
27704	SUPPL	2005-05-27
27705	SUPPL	2005-02-17
27706	SUPPL	2005-02-03
5291	SUPPL	2005-02-03
42142	ORIG	2003-03-07
36851	SUPPL	2003-01-17
27702	SUPPL	2003-01-17
15398	ORIG	2002-11-26
5290	ORIG	2002-11-26