Application 091169

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	1MG	No	No
002	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	2MG	No	No
003	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	3MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091169-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23
A091169-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23
A091169-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091169-001	AB
A091169-002	AB
A091169-003	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 1 of 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091169-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-05-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091169-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091169-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-05-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091169-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091169-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091169-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091169-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091169-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091169-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091169-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091169-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091169-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091169-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091169-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091169-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091169-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091169-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091169-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091169-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091169-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091169-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091169-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091169-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091169-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091169-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091169-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091169-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091169-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091169-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091169-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091169-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091169-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091169-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091169-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091169-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091169-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091169-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091169-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091169-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091169-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	Teva Pharmaceuticals USA, Inc.	2435e2f1-bc52-488f-80e9-f1758e354aae	2021-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091169 application number: ANDA091169 ndc (product): 0093-5538 ndc (product): 0093-5537 ndc (product): 0093-5539
Eszopiclone	ESZOPICLONE	Aphena Pharma Solutions - Tennessee, LLC	9bbf260f-3090-46b5-b3ef-81174697f166	2020-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091169 application number: ANDA091169 ndc (product): 71610-409

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
43353-097	Eszopiclone	Eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-101	Eszopiclone	Eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-1899	Eszopiclone	Eszopiclone	A-S Medication Solutions	ANDA	Current
50436-5538	Eszopiclone	Eszopiclone	Unit Dose Services	ANDA	Current
50436-5539	Eszopiclone	Eszopiclone	Unit Dose Services	ANDA	Current
71610-409	Eszopiclone	Eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9323	ORIG	2011-05-25