Application 202075

Type: ANDA
Sponsor: ACI HEALTHCARE LTD

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
002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	25MG	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
A202075-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2011-11-28
A202075-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2026-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202075-001	AB
A202075-002	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 2 · 42 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	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202075-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-11-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A202075-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202075-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202075-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202075-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202075-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202075-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202075-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202075-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202075-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202075-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202075-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202075-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202075-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202075-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202075-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202075-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202075-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202075-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202075-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202075-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202075-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202075-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202075-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202075-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202075-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202075-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202075-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202075-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202075-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202075-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202075-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202075-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202075-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202075-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202075-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202075-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202075-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202075-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202075-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202075-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	a886d551-6b57-4d9d-87f4-e1366385c7fd	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Northwind Health Company, LLC	1b5360f8-3e95-a047-e063-6294a90a7315	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	05f8e06b-f3eb-4cb2-aee5-bd0b03884178	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	c6104e62-5b2c-41a1-afb3-00dcf267a384	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1e79e1fa-3473-f4a7-e063-6294a90a9576	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	6ebc5864-c222-4400-a9b2-f66fd6fb0da6	2024-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	1cd3caee-bf54-7aba-e063-6394a90ad8cb	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	2236031d-8596-4c21-8b16-83aa3e4122c1	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202075 application number: ANDA202075

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69150-020	Tramadol Hydrochloride	Tramadol Hydrochloride	BIOMES PHARMACEUTICALS LLC	ANDA	Current
71093-119	tramadol hydrochloride	tramadol hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-119	tramadol hydrochloride	tramadol hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current
71093-119	tramadol hydrochloride	tramadol hydrochloride	ACI Healthcare USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76444	ORIG	2023-11-07