Application 091151

Type: ANDA
Sponsor: MYLAN PHARMS INC

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
A091151-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26
A091151-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26
A091151-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091151-001	AB
A091151-002	AB
A091151-003	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	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091151-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-03-26	`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	A091151-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091151-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091151-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091151-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091151-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091151-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091151-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091151-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091151-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091151-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091151-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091151-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091151-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091151-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091151-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091151-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091151-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	Golden State Medical Supply, Inc.	fef87d8d-f375-4b00-8765-957ef076bf1a	2023-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091151 application number: ANDA091151 ndc (product): 60429-634 ndc (product): 60429-633 ndc (product): 60429-632
Eszopiclone	ESZOPICLONE	Mylan Pharmaceuticals Inc.	5469cc59-78f9-447a-9c33-12553bb4073d	2022-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091151 application number: ANDA091151 ndc (product): 0378-5270 ndc (product): 0378-5271 ndc (product): 0378-5272

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5270	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5270	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5270	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5271	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5271	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5271	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5272	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5272	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5272	Eszopiclone	eszopiclone	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-185	Eszopiclone	eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-185	Eszopiclone	eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-200	Eszopiclone	eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-200	Eszopiclone	eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2606	Eszopiclone	eszopiclone	A-S Medication Solutions	ANDA	Current
51079-349	Eszopiclone	eszopiclone	Mylan Institutional Inc.	ANDA	Current
51079-349	Eszopiclone	eszopiclone	Mylan Institutional Inc.	ANDA	Current
51079-414	Eszopiclone	eszopiclone	Mylan Institutional Inc.	ANDA	Current
51079-414	Eszopiclone	eszopiclone	Mylan Institutional Inc.	ANDA	Current
60429-632	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-632	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-632	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-632	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-633	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-633	Eszopiclone	Eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-633	Eszopiclone	Eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-633	Eszopiclone	Eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-634	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-634	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-634	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current
60429-634	Eszopiclone	eszopiclone	Golden State Medical Supply, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43245	ORIG	2013-04-10