Application 090609

Type: ANDA
Sponsor: DR REDDYS LABS 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
A090609-001	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2018-02-23
A090609-002	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2018-02-23
A090609-003	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2018-02-23
A090609-004	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2018-02-23
A090609-005	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2018-02-23
A090609-006	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2018-02-23
A090609-007	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090609-001	AB
A090609-002	AB
A090609-003	AB
A090609-004	AB
A090609-005	AB
A090609-006	AB
A090609-007	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	A090609-001	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2018-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-002	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE	CAPSULE / ORAL	AB	2018-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-003	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2018-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-004	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2018-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-005	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2018-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-006	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2018-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-007	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-02-23	`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	A090609-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090609-007	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atomoxetine	ATOMOXETINE	REMEDYREPACK INC.	d7002d75-edad-4141-91bf-7eebf50ad1aa	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090609 application number: ANDA090609
Atomoxetine	ATOMOXETINE	Major Pharmaceuticals	f98c3424-1c43-43e4-8bca-2e3430f50c63	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090609 application number: ANDA090609 ndc (product): 0904-6908
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	b7f78a37-d525-42b7-813a-fa3e18ae7b74	2023-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090609 application number: ANDA090609 ndc (product): 63629-9427
Atomoxetine	ATOMOXETINE	Bryant Ranch Prepack	92de0ca1-6a02-4925-aefc-b32573d349a7	2023-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090609 application number: ANDA090609 ndc (product): 63629-9428
Atomoxetine	ATOMOXETINE	Dr. Reddy's Laboratories Limited	973bdc9b-6421-7e00-e2b6-3cce036d363e	2022-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090609 application number: ANDA090609 ndc (product): 55111-522 ndc (product): 55111-519 ndc (product): 55111-563 ndc (product): 55111-521 ndc (product): 55111-528 ndc (product): 55111-564 ndc (product): 55111-520

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6908	Atomoxetine	Atomoxetine	Major Pharmaceuticals	ANDA	Current
0904-6908	Atomoxetine	Atomoxetine	Major Pharmaceuticals	ANDA	Current
0904-6908	Atomoxetine	Atomoxetine	Major Pharmaceuticals	ANDA	Current
55111-519	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-519	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-519	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-519	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-520	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-520	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-520	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-520	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-521	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-521	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-521	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-521	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-522	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-522	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-522	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-522	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-528	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-528	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-528	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-528	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-563	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-563	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-563	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-563	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-564	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-564	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-564	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-564	Atomoxetine	Atomoxetine	Dr. Reddy's Laboratories Limited	ANDA	Current
63629-9427	Atomoxetine	Atomoxetine	Bryant Ranch Prepack	ANDA	Current
63629-9428	Atomoxetine	Atomoxetine	Bryant Ranch Prepack	ANDA	Current