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 43.

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091153-001	ESZOPICLONE	1MG	TABLET / ORAL	2014-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091153-002	ESZOPICLONE	2MG	TABLET / ORAL	2014-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091153-003	ESZOPICLONE	3MG	TABLET / ORAL	2014-04-15	`caaa826d4ba7…`
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…`

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 4 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	Proficient Rx LP	1582ba77-a4e3-464f-876b-28cc7e41e8f1	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: Eszopiclone generic name: ESZOPICLONE
ESZOPICLONE	ESZOPICLONE	Sun Pharmaceutical Industries, Inc.	8bb1965e-7845-4c5b-b021-38e251303d68	2018-10-25	Warnings, Adverse reactions	Name fallback brand name: ESZOPICLONE generic name: ESZOPICLONE

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 · 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