Application 208708

Type: ANDA
Sponsor: RUBICON

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	100MG	No	No
003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
004	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208708-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28
A208708-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28
A208708-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-11-27
A208708-004	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208708-001	AB
A208708-002	AB
A208708-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL	AB		2023-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-003	TRAMADOL HYDROCHLORIDE	25MG	TABLET / ORAL			2023-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208708-004	TRAMADOL HYDROCHLORIDE	75MG	TABLET / ORAL			2024-04-04	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 77 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A208708-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208708-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208708-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208708-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208708-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208708-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208708-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208708-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208708-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208708-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208708-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208708-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208708-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208708-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208708-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208708-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208708-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208708-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208708-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208708-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208708-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208708-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208708-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208708-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208708-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208708-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208708-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208708-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208708-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208708-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208708-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208708-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208708-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208708-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208708-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208708-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208708-003	AB	1	`a50c72e98297…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Northwind Health Company, LLC	552955e6-2bb3-8755-e063-6394a90ab21c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	5199132e-745e-46a0-8068-e06d1bca5c61	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	674803a0-4cf5-4416-a5e3-c1a1e332cdcd	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advagen Pharma Limited	93b12089-3a0f-4b57-abb1-2429cf31995d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708 ndc (product): 72888-080 ndc (product): 72888-008
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	RedPharm Drug Inc	f4c148f3-845a-61e3-e053-2a95a90a326e	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	84b12129-cf10-4a3e-889c-990ebabdece6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708 ndc (product): 68788-8121
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	2bf66203-8b45-475d-9a70-4d7c8bdfe6b3	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	6a60bd36-7dcc-49c3-b6de-b263fdaa312c	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	3135a131-5f2d-3775-e063-6394a90a4322	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRx	d5685c80-c84d-d0a1-e053-2995a90afc54	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708 ndc (product): 72189-311
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	d7e75fd3-18d1-4370-bb63-c9dd8a2c1719	2025-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4ea18b0-2cbd-0d42-e053-2995a90a9264	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	f79fda81-f09a-4a08-babc-6bd3bb3ee661	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f44c53ec-26ea-d272-e053-2a95a90a5e59	2024-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	TRUPHARMA LLC	61fb5ba7-6896-4ee4-83de-caee69b06a8e	2021-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208708 application number: ANDA208708 ndc (product): 52817-195 ndc (product): 52817-196

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52817-195	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
52817-195	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
52817-195	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
52817-195	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
52817-196	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
52817-196	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
52817-196	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
52817-196	Tramadol Hydrochloride	Tramadol Hydrochloride	TRUPHARMA LLC	ANDA	Current
68788-8121	Tramadol Hydrochloride	Tramadol Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
72189-311	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRx	ANDA	Current
72189-311	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRx	ANDA	Current
72888-007	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-007	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-007	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-008	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-008	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-008	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-008	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-080	Tramadol Hydrochloride	Tramadol Hydrochloride	Advagen Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83686	SUPPL	2025-10-07
83685	SUPPL	2025-10-07
79315	SUPPL	2024-08-06
76445	ORIG	2023-11-07
59236	ORIG	2019-07-05