Application 077903

Type: ANDA
Sponsor: TORRENT PHARMS

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 1.

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
A077903-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-08-17
A077903-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077903-001	AB
A077903-002	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 · 82 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	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A077903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077903-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077903-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077903-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077903-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077903-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077903-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077903-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077903-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077903-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077903-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077903-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077903-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077903-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077903-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077903-002	AB	1	`782e0a99824c…`

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	507225e2-80ba-18c4-e054-00144ff88e88	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 60760-288
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Torrent Pharmaceuticals Limited	1584bad1-7bf4-4805-bdd9-7eb0fac92721	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 13668-007 ndc (product): 13668-008
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	89cfb1d5-437c-4c13-8f9b-b6851ffba87b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 60760-515
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	2abdcf77-d3ed-42bc-acd9-545aab75d567	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Calvin Scott & Co., Inc.	7da75d2b-905c-4fdf-bc53-1358c6477755	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	59cc61da-838e-4add-b2d6-42b2b283a000	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 50090-1022
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Direct_Rx	907c7b18-2638-512c-e053-2995a90ae6fd	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Northwind Health Company, LLC	26e20f53-c042-eac0-e063-6394a90acfca	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Cardinal Health 107, LLC	83510333-f07d-4b81-a3ae-2801d114bd31	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 55154-1398
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc.	a9ac3d4e-f502-41e3-95c0-0d334584566d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Major Pharmaceuticals	d34336b1-7041-4078-beda-94bc9d9f771e	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 0904-6082 ndc (product): 0904-6083
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2025-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87ae17-a3c5-a3a5-e053-2a95a90aa4b0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c8adec28-9dcd-4a7e-e053-2a95a90a991e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	fc76ab4c-3607-39c3-e053-6394a90a6877	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	f939549f-14a6-d37c-e053-6294a90a034a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lake Erie Medical DBA Quality Care Products LLC	db735db9-1c82-4d32-bf91-97b05a75e876	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 55700-357
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	95b0ba48-4e71-25f7-e053-2a95a90aea82	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	413b6f65-101e-e2cf-0802-711d080b851b	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3bbc3c35-2811-4a67-9dcc-5eed38ef8b52	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 160 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6082	ZOLPIDEM TARTRATE	zolpidem tartrate	Major Pharmaceuticals	ANDA	Current
0904-6082	ZOLPIDEM TARTRATE	zolpidem tartrate	Major Pharmaceuticals	ANDA	Current
0904-6082	ZOLPIDEM TARTRATE	zolpidem tartrate	Major Pharmaceuticals	ANDA	Current
0904-6083	ZOLPIDEM TARTRATE	zolpidem tartrate	Major Pharmaceuticals	ANDA	Current
0904-6083	ZOLPIDEM TARTRATE	zolpidem tartrate	Major Pharmaceuticals	ANDA	Current
13668-007	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-007	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-007	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-007	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-007	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-007	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-007	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-008	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-008	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-008	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-008	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-008	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-008	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-008	ZOLPIDEM TARTRATE	zolpidem tartrate	Torrent Pharmaceuticals Limited	ANDA	Current
21695-506	ZOLPIDEM TARTRATE	zolpidem tartrate	Rebel Distributors Corp.	ANDA	Current
21695-507	ZOLPIDEM TARTRATE	zolpidem tartrate	Rebel Distributors Corp.	ANDA	Current
33261-172	ZOLPIDEM TARTRATE	zolpidem tartrate	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-173	ZOLPIDEM TARTRATE	zolpidem tartrate	Aidarex Pharmaceuticals LLC	ANDA	Current
33358-420	ZOLPIDEM TARTRATE	zolpidem tartrate	RxChange Co.	ANDA	Current
33358-439	ZOLPIDEM TARTRATE	zolpidem tartrate	RxChange Co.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-639	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-652	ZOLPIDEM TARTRATE	zolpidem tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-242	ZOLPIDEM TARTRATE	zolpidem tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-242	ZOLPIDEM TARTRATE	zolpidem tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-243	ZOLPIDEM TARTRATE	zolpidem tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-243	ZOLPIDEM TARTRATE	zolpidem tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45865-409	ZOLPIDEM TARTRATE	zolpidem tartrate	Medsource Pharmaceuticals	ANDA	Current
45865-413	ZOLPIDEM TARTRATE	zolpidem tartrate	Medsource Pharmaceuticals	ANDA	Current
50090-1022	ZOLPIDEM TARTRATE	zolpidem tartrate	A-S Medication Solutions	ANDA	Current
50090-1022	ZOLPIDEM TARTRATE	zolpidem tartrate	A-S Medication Solutions	ANDA	Current
50090-1022	ZOLPIDEM TARTRATE	zolpidem tartrate	A-S Medication Solutions	ANDA	Current
50090-1023	ZOLPIDEM TARTRATE	zolpidem tartrate	A-S Medication Solutions	ANDA	Current
50090-1023	ZOLPIDEM TARTRATE	zolpidem tartrate	A-S Medication Solutions	ANDA	Current
50436-0007	ZOLPIDEM TARTRATE	zolpidem tartrate	Unit Dose Services	ANDA	Current
50436-0008	ZOLPIDEM TARTRATE	zolpidem tartrate	Unit Dose Services	ANDA	Current
52959-879	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	H.J Harkins Company Inc.	ANDA	Current
52959-879	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	H. J. Harkins Co., Inc.	ANDA	Current
52959-880	ZOLPIDEM TARTRATE	zolpidem tartrate	H.J. Harkins Company, Inc.	ANDA	Current
53002-1292	ZOLPIDEM TARTRATE	zolpidem tartrate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1292	ZOLPIDEM TARTRATE	zolpidem tartrate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-5020	ZOLPIDEM TARTRATE	zolpidem tartrate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-5020	ZOLPIDEM TARTRATE	zolpidem tartrate	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-1398	ZOLPIDEM TARTRATE	zolpidem tartrate	Cardinal Health	ANDA	Current
55154-1398	ZOLPIDEM TARTRATE	zolpidem tartrate	Cardinal Health	ANDA	Current
55154-1398	ZOLPIDEM TARTRATE	zolpidem tartrate	Cardinal Health 107, LLC	ANDA	Current
55700-268	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-268	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-268	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-357	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-357	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-357	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-357	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-357	ZOLPIDEM TARTRATE	zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-288	ZOLPIDEM TARTRATE	zolpidem tartrate	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-288	ZOLPIDEM TARTRATE	zolpidem tartrate	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-288	ZOLPIDEM TARTRATE	zolpidem tartrate	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-515	ZOLPIDEM TARTRATE	zolpidem tartrate	St Marys Medical Park Pharmacy	ANDA	Current
60760-515	ZOLPIDEM TARTRATE	zolpidem tartrate	St Marys Medical Park Pharmacy	ANDA	Current
60760-515	ZOLPIDEM TARTRATE	zolpidem tartrate	St Marys Medical Park Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23891	ORIG	2007-08-24