Application 091103

Type: ANDA
Sponsor: SUN PHARM

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 42.

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
A091103-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03
A091103-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03
A091103-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091103-001	AB
A091103-002	AB
A091103-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2013-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2013-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2013-04-03	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091103-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091103-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091103-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091103-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091103-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091103-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091103-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091103-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091103-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091103-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091103-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091103-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091103-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091103-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091103-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091103-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091103-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091103-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091103-001	AB	1	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESZOPICLONE	ESZOPICLONE	Sun Pharmaceutical Industries, Inc.	8bb1965e-7845-4c5b-b021-38e251303d68	2018-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091103 application number: ANDA091103 ndc (product): 47335-588 ndc (product): 47335-586 ndc (product): 47335-587

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-828	ESZOPICLONE	ESZOPICLONE	Medsource Pharmaceuticals	ANDA	Current
45865-828	ESZOPICLONE	ESZOPICLONE	Medsource Pharmaceuticals	ANDA	Current
45865-829	ESZOPICLONE	ESZOPICLONE	Medsource Pharmaceuticals	ANDA	Current
45865-829	ESZOPICLONE	ESZOPICLONE	Medsource Pharmaceuticals	ANDA	Current
45865-830	ESZOPICLONE	ESZOPICLONE	Medsource Pharmaceuticals	ANDA	Current
45865-830	ESZOPICLONE	ESZOPICLONE	Medsource Pharmaceuticals	ANDA	Current
47335-586	ESZOPICLONE	ESZOPICLONE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-587	ESZOPICLONE	ESZOPICLONE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-588	ESZOPICLONE	ESZOPICLONE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50436-5537	ESZOPICLONE	ESZOPICLONE	Unit Dose Services	ANDA	Current
61919-500	ESZOPICLONE	ESZOPICLONE	Direct Rx	ANDA	Current
61919-500	ESZOPICLONE	ESZOPICLONE	Direct Rx	ANDA	Current
61919-502	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
63629-5319	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
63629-5319	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
63629-5319	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
63629-5319	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
63629-5325	ESZOPICLONE	ESZOPICLONE	Bryant Ranch Prepack	ANDA	Current
68788-9296	ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9824	ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9991	ESZOPICLONE	ESZOPICLONE	Preferred Pharmaceuticals, Inc.	ANDA	Current