Application 207152

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	TABLET;ORAL	325MG;37.5MG	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
A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL	AB		2017-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207152-001	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	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207152-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2017-03-22	`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	A207152-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207152-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207152-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207152-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207152-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207152-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207152-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207152-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207152-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207152-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207152-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207152-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207152-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207152-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207152-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207152-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207152-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207152-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207152-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207152-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207152-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207152-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207152-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207152-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207152-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207152-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207152-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207152-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207152-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207152-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207152-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207152-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207152-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207152-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207152-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207152-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207152-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207152-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207152-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207152-001	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 and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	cb05d615-918d-8104-e053-2995a90aa96b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152 ndc (product): 60760-922
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Bryant Ranch Prepack	ccf465b5-8ef8-4445-a0d4-23b5cf13188c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152 ndc (product): 71335-1742
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Bryant Ranch Prepack	c83366d9-db60-45eb-9c2b-a2c58d45c82c	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Aurobindo Pharma Limited	6c2894df-eeeb-4b22-ab32-8ce1601bfdfa	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152 ndc (product): 65862-922
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	REMEDYREPACK INC.	5058c2b0-5c66-4cd2-80a6-7a4678c1fd51	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Direct_Rx	e8a7c995-e473-ca87-e053-2995a90a5b80	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152 ndc (product): 72189-382
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Medsource Pharmaceuticals	12f113b3-d6b1-a7b0-e063-6294a90a999d	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Proficient Rx LP	d9fa3057-c7a5-46cf-a79e-abf99a4f804d	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207152 application number: ANDA207152 ndc (product): 71205-625

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3248	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	A-S Medication Solutions	ANDA	Current
60760-922	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	St. Mary's Medical Park Pharmacy	ANDA	Current
65862-922	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Aurobindo Pharma Limited	ANDA	Current
65862-922	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Aurobindo Pharma Limited	ANDA	Current
65862-922	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Aurobindo Pharma Limited	ANDA	Current
65862-922	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Aurobindo Pharma Limited	ANDA	Current
65862-922	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Aurobindo Pharma Limited	ANDA	Current
68071-2351	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2351	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-625	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Proficient Rx LP	ANDA	Current
71205-625	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Proficient Rx LP	ANDA	Current
71335-1742	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1742	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
72189-382	Tramadol Hydrochloride and Acetaminophen	Tramadol Hydrochloride and Acetaminophen	Direct_Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76055	ORIG	2023-11-02