Application 078483

Type: ANDA
Sponsor: SYNTHON PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET, EXTENDED RELEASE;ORAL	6.25MG	No	No
002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET, EXTENDED RELEASE;ORAL	12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078483-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL			2011-04-12
A078483-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL			2011-06-06

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 3 · 86 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	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078483-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	2011-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078483-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-06	`74a2ff9319b5…`

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 5 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DirectRX	25f1176d-5195-1a99-e054-00144ff8d46c	2024-06-26	Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	98e5208b-5109-58c6-e053-2995a90a994a	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	92c6cc45-c28b-729b-e053-2a95a90a7ccb	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	78481108-4a1c-fce9-e053-2a91aa0a09ad	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1a8a8072-39bf-44c5-e063-6294a90a77c3	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem tartrate	ZOLPIDEM TARTRATE	Sandoz Inc	b1b0085f-d9fe-430a-9bd5-607f607bf7e1	2024-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem tartrate generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	08411424-e8a8-4964-bd04-5b0b5aa5baaf	2024-04-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	70d7cfc3-7e54-4cd8-8911-7cf115d5c820	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	23bce69d-7918-42c2-8020-e22f292ff31f	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3aa7e88b-7929-45ac-9e81-03f4abf28e94	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	1e5b61b6-a5bd-4f09-9d34-905ce32f1899	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aurobindo Pharma Limited	ea2067bd-1622-4d98-8012-2c09405aa88d	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NorthStar Rx LLC	51c9a29c-a285-40d0-bf3a-7e8c944ee39c	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	39d91478-ea0e-407e-b5cb-0eeb592e0aa4	2024-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	df130798-1458-455b-a4e1-c33c4ecee43b	2023-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	33094305-4bbd-4b52-9079-8853d5f83682	2023-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	ACI Healthcare USA, Inc	021153ce-fe27-4ed1-8d88-b4157b0ed734	2023-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Sun Pharmaceutical Industries, Inc.	0c64bc71-2e7f-4b15-a8e1-acb8de04395f	2023-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	e68a1b3b-b3d1-495e-be46-466113e7dbd6	2023-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZOLPIDEM TARTRATE generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	67cc924a-26e0-431f-9160-32c9d92a46cd	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zolpidem Tartrate generic name: ZOLPIDEM TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.