Application 203494

Type: ANDA
Sponsor: AUROBINDO PHARMA 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

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
A203494-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2014-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203494-001	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	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203494-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-03-31	`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	A203494-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203494-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203494-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203494-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203494-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203494-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203494-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203494-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203494-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203494-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203494-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203494-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203494-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203494-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203494-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203494-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203494-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203494-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203494-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203494-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203494-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203494-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203494-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203494-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203494-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203494-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203494-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203494-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203494-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203494-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203494-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203494-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203494-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203494-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203494-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203494-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203494-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203494-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203494-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203494-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	f2f421ab-35ae-7637-e053-2995a90a40e0	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494 ndc (product): 16571-716
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aurobindo Pharma Limited	e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494 ndc (product): 59651-441
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	e90d4ef3-8b90-41b7-bf96-340852e89b5f	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203494 application number: ANDA203494

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-716	Tramadol Hydrochloride	Tramadol Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
57237-238	Tramadol Hydrochloride	Tramadol Hydrochloride	Citron Pharma LLC	ANDA	Current
59651-441	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-441	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-441	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-441	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-441	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-667	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-667	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-667	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-667	Tramadol Hydrochloride	Tramadol Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
70518-3586	Tramadol Hydrochloride	Tramadol Hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76335	ORIG	2023-11-03