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 44.

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.

Product history page 4 of 8 · 308 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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090609-002	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2018-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090609-003	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090609-004	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2018-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090609-005	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2018-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090609-006	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2018-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090609-007	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2018-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090609-001	ATOMOXETINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090609-002	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090609-003	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090609-004	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090609-005	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090609-006	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090609-007	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090609-001	ATOMOXETINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090609-002	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090609-003	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090609-004	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090609-005	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090609-006	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090609-007	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090609-001	ATOMOXETINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090609-002	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090609-003	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090609-004	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090609-005	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090609-006	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090609-007	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090609-001	ATOMOXETINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090609-002	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090609-003	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090609-004	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090609-005	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090609-006	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090609-007	ATOMOXETINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090609-001	ATOMOXETINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2018-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090609-002	ATOMOXETINE HYDROCHLORIDE	18MG	CAPSULE / ORAL	AB	2018-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090609-003	ATOMOXETINE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	2018-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090609-004	ATOMOXETINE HYDROCHLORIDE	40MG	CAPSULE / ORAL	AB	2018-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090609-005	ATOMOXETINE HYDROCHLORIDE	60MG	CAPSULE / ORAL	AB	2018-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090609-006	ATOMOXETINE HYDROCHLORIDE	80MG	CAPSULE / ORAL	AB	2018-02-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090609-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090609-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090609-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090609-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090609-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090609-006	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090609-007	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090609-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090609-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090609-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090609-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090609-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090609-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090609-007	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090609-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090609-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090609-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090609-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090609-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090609-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090609-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090609-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090609-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090609-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090609-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090609-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090609-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090609-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090609-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090609-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090609-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090609-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090609-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090609-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090609-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090609-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090609-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090609-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090609-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090609-005	AB	1	`6a471c1ec25d…`

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 · 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	2026-09-04	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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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