Application 211825

Type: ANDA
Sponsor: UNICHEM LABS 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
A211825-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2019-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211825-001	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.

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	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211825-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2019-08-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211825-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211825-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211825-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211825-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211825-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211825-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211825-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211825-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211825-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211825-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211825-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211825-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211825-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211825-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211825-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211825-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211825-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211825-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211825-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211825-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211825-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211825-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211825-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211825-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211825-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211825-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211825-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211825-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211825-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211825-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211825-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211825-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211825-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211825-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211825-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211825-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211825-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211825-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211825-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211825-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	007bf37f-0e46-426a-ac8c-be63d4b7414c	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825 ndc (product): 29300-355
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	4a525cf7-2c0c-47c6-aed3-3a395a7120ec	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825 ndc (product): 50090-5790
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	f9282800-fde7-477a-8b8f-59617ec26f73	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825 ndc (product): 50090-5789
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	18d9e3e4-5892-43b8-b211-3ef3393ad946	2026-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3d719560-7449-f970-e063-6294a90a9bd8	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f558c59c-cbd4-4b17-9a3d-b014ad09bbb1	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e6e275c3-1e16-4a00-b7fd-608ae6cbd515	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211825 application number: ANDA211825

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-355	Tramadol Hydrochloride	Tramadol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-355	Tramadol Hydrochloride	Tramadol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-355	Tramadol Hydrochloride	Tramadol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-355	Tramadol Hydrochloride	Tramadol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-355	Tramadol Hydrochloride	Tramadol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-5789	Tramadol Hydrochloride	Tramadol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5790	Tramadol Hydrochloride	Tramadol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5790	Tramadol Hydrochloride	Tramadol Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5790	Tramadol Hydrochloride	Tramadol Hydrochloride	A-S Medication Solutions	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76471	ORIG	2023-11-07