Application 076003

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076003-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076003-001	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 2 · 41 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	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076003-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	AB	1	`cb3db0bc1861…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	54d74939-301b-e603-e063-6394a90a3b03	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Major Pharmaceuticals	6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003 ndc (product): 69238-2348
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	8ec4e4e5-a56e-4198-8428-6b770b9bf27d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	American Health Packaging	f6f6069b-cc75-4b87-afa5-b83001b543e0	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2e738ced-9cde-e776-e063-6294a90a7e33	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	728157e2-d153-4ea0-81eb-36599dc7dfda	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5babcfcf-331b-5db9-e053-2a91aa0aaf89	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003 ndc (product): 68071-4119
Tramadol HCL	TRAMADOL HCL	Advanced Rx of Tennessee, LLC	af87fc31-07c2-b1f7-e053-2995a90a499f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003 ndc (product): 80425-0057
TRAMADOL HCL ER	TRAMADOL HCL	DIRECT RX	5285f056-c32c-4e7a-bec6-3a726aa23d5a	2024-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 61919-073
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	58b802cb-2443-4f5b-9718-7d54c6d50cb4	2021-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003 ndc (product): 65162-627
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	50f4b752-20af-4ebf-9408-e78f30d2a3cc	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003 ndc (product): 63187-063

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 85 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8005	Tramadol Hydrochloride	Tramadol Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8005	Tramadol Hydrochloride	Tramadol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8005	Tramadol Hydrochloride	Tramadol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-009	Tramadol Hydrochloride	Tramadol Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-531	Tramadol Hydrochloride	Tramadol Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
12634-786	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	APOTHECA, INC	ANDA	Current
21695-132	Tramadol Hydrochloride	Tramadol Hydrochloride	Rebel Distributors Corp.	ANDA	Current
24236-609	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
33261-105	Tramadol Hydrochloride	Tramadol Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
33358-342	Tramadol Hydrochloride	Tramadol Hydrochloride	RxChange Co.	ANDA	Current
35356-659	Tramadol Hydrochloride	Tramadol Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
43353-072	Tramadol Hydrochloride	Tramadol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2099	Tramadol Hydrochloride	Tramadol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2100	Tramadol Hydrochloride	Tramadol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3000	Tramadol Hydrochloride	Tramadol Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-8787	Tramadol Hydrochloride	Tramadol Hydrochloride	Unit Dose Services	ANDA	Current
50436-8787	Tramadol Hydrochloride	Tramadol Hydrochloride	Unit Dose Services	ANDA	Current
51138-077	Tramadol Hydrochloride	Tramadol Hydrochloride	Med-Health Pharma, LLC	ANDA	Current
51655-185	Ultram	TRAMADOL HCL	NORTHWIND PHARMACEUTICALS	ANDA	Current
53002-4320	Tramadol Hydrochloride	Tramadol Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4320	Tramadol Hydrochloride	Tramadol Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
60760-622	Tramadol Hydrochloride	Tramadol Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-073	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-063	Tramadol Hydrochloride	Tramadol Hydrochloride	Proficient Rx LP	ANDA	Current
63187-063	Tramadol Hydrochloride	Tramadol Hydrochloride	Proficient Rx LP	ANDA	Current
63629-4899	Tramadol Hydrochloride	Tramadol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4899	Tramadol Hydrochloride	Tramadol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4899	Tramadol Hydrochloride	Tramadol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63739-671	Tramadol Hydrochloride	Tramadol Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63874-532	Tramadol Hydrochloride	Tramadol Hydrochloride	Altura Pharmaceuticals, Inc.	ANDA	Current
64205-627	Tramadol Hydrochloride	Tramadol Hydrochloride	ReadyMeds	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
66267-563	Tramadol Hydrochloride	Tramadol Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-563	Tramadol Hydrochloride	Tramadol Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-843	Tramadol Hydrochloride	Tramadol Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-843	Tramadol Hydrochloride	Tramadol Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-730	Tramadol Hydrochloride	Tramadol Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67296-0389	Tramadol Hydrochloride	Tramadol Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-4119	Tramadol Hydrochloride	Tramadol Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4119	Tramadol Hydrochloride	Tramadol Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4119	Tramadol Hydrochloride	Tramadol Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-808	Tramadol Hydrochloride	Tramadol Hydrochloride	American Health Packaging	ANDA	Current
68084-808	Tramadol Hydrochloride	Tramadol Hydrochloride	American Health Packaging	ANDA	Current
68084-808	Tramadol Hydrochloride	Tramadol Hydrochloride	American Health Packaging	ANDA	Current
68084-808	Tramadol Hydrochloride	Tramadol Hydrochloride	American Health Packaging	ANDA	Current
68094-017	Tramadol Hydrochloride	Tramadol Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-017	Tramadol Hydrochloride	Tramadol Hydrochloride	Precision Dose, Inc.	ANDA	Current
68387-900	Tramadol Hydrochloride	Tramadol Hydrochloride	Keltman Pharmaceuticals Inc.	ANDA	Current
68788-9199	Tramadol Hydrochloride	Tramadol Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
69238-2348	Tramadol Hydrochloride	Tramadol Hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
70518-0054	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0118	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71610-392	Tramadol Hydrochloride	Tramadol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
75921-627	Tramadol Hydrochloride	Tramadol Hydrochloride	Life Line Home Care Services, Inc.	ANDA	Current
80425-0057	Ultram	Tramadol HCl 50mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76305	ORIG	2023-11-03
18437	ORIG	2002-06-20
8847	ORIG	2002-06-20