Application 091153

Type: ANDA
Sponsor: HIKMA

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	Approval date
A091153-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15
A091153-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15
A091153-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091153-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091153-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091153-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091153-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091153-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091153-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091153-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091153-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091153-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091153-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091153-003	AB	1	`ea99ee380514…`

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	St Mary's Medical Park Pharmacy	c4ff1d6a-918e-c046-e053-2a95a90a9c9b	2026-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	2b5b4fbb-9b86-46c6-9508-37d3d9806dec	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals, Inc.	45558f0a-83f1-49b9-ab18-f436c0be9677	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	REMEDYREPACK INC.	61fd4655-060f-4393-a610-019d8b127058	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	abe3a610-a25d-4b52-8537-c87e8ba3104a	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Preferred Pharmaceuticals Inc.	0102ea59-77b1-4e74-83ec-1d205563b55f	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	NuCare Pharmaceuticals,Inc.	c24ec179-f869-746f-e053-2995a90aa1ff	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Asclemed USA, Inc.	838559f7-4b69-4831-bf50-ab37c6c24c2b	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	DIRECT RX	486b760b-7fea-306b-e054-00144ff8d46c	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Proficient Rx LP	dd7e4bab-8e25-4788-89e4-6b391f9596fe	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Glenmark Pharmaceuticals Inc. USA	584dc66c-063a-4552-a056-74b811e2bc80	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	REMEDYREPACK INC.	7df922bc-5750-4259-906f-64f960c38d5f	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	57a8450c-59ee-4c96-bef4-308fa7b97d1e	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	bfa767ce-340b-4d3a-a9c7-0043b6d7ff6e	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	e261bf7f-1b89-4393-8c48-4e72fc29192f	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	A-S Medication Solutions	923cc646-f22a-4a26-88f7-a19fce016321	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	4832cfbf-a540-46af-bb7d-3ba8e6bc783e	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	bb972d36-4b2c-45ae-8504-3a16d352dd8b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE
Eszopiclone	ESZOPICLONE	Bryant Ranch Prepack	f6022b2f-9b43-40cc-91c7-c224b209efab	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0290	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0290	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0290	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0291	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0291	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0291	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0292	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0292	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0292	eszopiclone	eszopiclone	West-Ward Pharmaceuticals Corp.	ANDA	Current
55700-132	eszopiclone	eszopiclone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-133	eszopiclone	eszopiclone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-462	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
61919-462	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
63187-180	eszopiclone	eszopiclone	Proficient Rx LP	ANDA	Current
63187-330	eszopiclone	eszopiclone	Proficient Rx LP	ANDA	Current
63187-365	eszopiclone	eszopiclone	Proficient Rx LP	ANDA	Current
68071-2153	eszopiclone	eszopiclone	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9238	eszopiclone	eszopiclone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9361	eszopiclone	eszopiclone	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-0784	eszopiclone	eszopiclone	Bryant Ranch Prepack	ANDA	Current
71335-0784	eszopiclone	eszopiclone	Bryant Ranch Prepack	ANDA	Current
71335-0784	eszopiclone	eszopiclone	Bryant Ranch Prepack	ANDA	Current