Application 075982

Type: ANDA
Sponsor: PLIVA

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 43.

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
A075982-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL			2002-07-01

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 · 43 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
2026-09-14 22:38:34	2026-08	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075982-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075982-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075982-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075982-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075982-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075982-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075982-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075982-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075982-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075982-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075982-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075982-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075982-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075982-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075982-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075982-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075982-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075982-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075982-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075982-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075982-001	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 5 of 5 · 91 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	0bff5535-0239-409e-8a2a-99d5ba38cca3	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	00b7f61b-5173-43e6-a3f9-d2efbda40c19	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	dce0d21e-e4c2-4875-a2ce-9d53df190b80	2022-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	3c187736-ea96-4e59-9fe6-cb625a619c63	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	27495d02-8641-4c92-b5a3-edf50abc2a6f	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	68646295-49b2-45ac-bf19-99bb91f7333d	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	f63facd7-519b-4e2b-b54f-c17fc9ede55f	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	58b802cb-2443-4f5b-9718-7d54c6d50cb4	2021-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	TRUPHARMA LLC	61fb5ba7-6896-4ee4-83de-caee69b06a8e	2021-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	50f4b752-20af-4ebf-9408-e78f30d2a3cc	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e	2019-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76146	ORIG	2023-11-03