Application 078413

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET;ORAL	5MG	No	No
002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET;ORAL	10MG	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
A078413-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-05-04
A078413-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-05-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078413-001	AB
A078413-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A078413-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078413-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078413-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078413-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078413-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078413-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078413-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078413-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078413-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078413-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078413-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078413-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078413-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078413-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078413-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078413-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078413-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078413-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078413-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078413-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078413-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078413-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078413-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078413-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078413-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078413-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078413-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078413-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078413-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078413-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078413-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078413-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078413-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078413-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078413-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078413-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078413-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078413-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078413-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078413-002	AB	1	`f41ea6bd6efb…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	cf3dcbde-b92a-4802-98e4-14f00abdf99e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	2556c804-7a5e-4dbd-aeef-a3ba3a247c39	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 50090-6070
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	f67ef513-1b2c-42fe-bf33-4c7e9db191a3	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 50090-2649
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	91511d2f-7066-49a0-90ea-2940d955c85e	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 50090-3879
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	ef72eb73-d058-4ca3-9013-691aae8426fb	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 50090-3878
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	9922ce14-b418-4235-9c59-d674a8e70210	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	38c838a4-9943-445a-8e80-e823d56eeaa5	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	fda413e7-b1ae-312a-e053-6394a90ab2c6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals, Inc.	2b9f696a-b637-4dea-e063-6394a90aeb2e	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87df4e-2c97-e23e-e053-2a95a90ab354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 80425-0061
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	b2db3979-daa6-6e83-e053-2a95a90a3a2f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 80425-0087
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c859c752-8a85-2017-e053-2a95a90a771f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 80425-0153
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	3ba3c29f-3835-4f4f-a39f-56fb42686f5b	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	American Health Packaging	eb850154-4b4b-4d9a-8476-aea1a93fe8d7	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aurobindo Pharma Limited	ea2067bd-1622-4d98-8012-2c09405aa88d	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 65862-159 ndc (product): 65862-160
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NorthStar Rx LLC	51c9a29c-a285-40d0-bf3a-7e8c944ee39c	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 16714-621 ndc (product): 16714-622
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	67cc924a-26e0-431f-9160-32c9d92a46cd	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 50090-5095
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	acfcfe91-83a0-44ab-95c0-dd98b73ac69a	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 71610-192
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7be7f243-e6f8-406f-aed7-be7cedd5630a	2018-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 71610-156
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7abb6898-223c-487b-856c-068ac04f7a5c	2018-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413 ndc (product): 71610-151 ndc (product): 71610-152

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 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8225	Zolpidem Tartrate	Zolpidem Tartrate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8225	Zolpidem Tartrate	Zolpidem Tartrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8226	Zolpidem Tartrate	Zolpidem Tartrate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8226	Zolpidem Tartrate	Zolpidem Tartrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
16714-621	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
16714-621	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
16714-621	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
16714-621	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
16714-622	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
16714-622	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
16714-622	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
16714-622	Zolpidem Tartrate	Zolpidem Tartrate	NorthStar Rx LLC	ANDA	Current
50090-2649	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3878	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3878	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3878	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3878	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3878	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3879	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3879	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3879	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3879	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-3879	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-5095	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-5096	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
50090-6070	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
63739-526	Zolpidem Tartrate	Zolpidem Tartrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-526	Zolpidem Tartrate	Zolpidem Tartrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-526	Zolpidem Tartrate	Zolpidem Tartrate	McKesson Corporation dba SKY Packaging	ANDA	Current
65862-159	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-159	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-159	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-159	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-160	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-160	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-160	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-160	Zolpidem Tartrate	Zolpidem Tartrate	Aurobindo Pharma Limited	ANDA	Current
67296-0537	Zolpidem Tartrate	Zolpidem Tartrate	RedPharm Drug, Inc.	ANDA	Current
68788-9282	Zolpidem Tartrate	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
71610-151	Zolpidem Tartrate	Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-152	Zolpidem Tartrate	Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-156	Zolpidem Tartrate	Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-192	Zolpidem Tartrate	Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0061	Ambien	Zolpidem Tartrate 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0061	Ambien	Zolpidem Tartrate 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0061	Zolpidem Tartrate	Zolpidem Tartrate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0061	Zolpidem Tartrate	Zolpidem Tartrate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0087	Ambien	Zolpidem Tartrate 5mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0087	Zolpidem Tartrate	Zolpidem Tartrate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0087	Zolpidem Tartrate	Zolpidem Tartrate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0153	Ambien	Zolpidem Tartrate 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0153	Zolpidem Tartrate	Zolpidem Tartrate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0153	Zolpidem Tartrate	Zolpidem Tartrate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0153	Zolpidem Tartrate	Zolpidem Tartrate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44381	ORIG	2007-05-15