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 3 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	RedPharm Drug Inc	f4c148f3-845a-61e3-e053-2a95a90a326e	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f558c59c-cbd4-4b17-9a3d-b014ad09bbb1	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	83367367-5654-4078-831a-69ade48bc795	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	05f8e06b-f3eb-4cb2-aee5-bd0b03884178	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tramadol hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	c30f6e9e-8014-40fc-9615-a6b8654137c1	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	84b12129-cf10-4a3e-889c-990ebabdece6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e6e275c3-1e16-4a00-b7fd-608ae6cbd515	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	2bf66203-8b45-475d-9a70-4d7c8bdfe6b3	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	c28c98ac-7e07-46a5-8f34-57c008308fba	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	American Health Packaging	f6f6069b-cc75-4b87-afa5-b83001b543e0	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	6a60bd36-7dcc-49c3-b6de-b263fdaa312c	2025-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	3135a131-5f2d-3775-e063-6394a90a4322	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Coupler LLC	2f23ba6c-89d2-cc42-e063-6394a90aee0a	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2e738ced-9cde-e776-e063-6294a90a7e33	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	728157e2-d153-4ea0-81eb-36599dc7dfda	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5babcfcf-331b-5db9-e053-2a91aa0aaf89	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRx	d5685c80-c84d-d0a1-e053-2995a90afc54	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	b3c702f7-0a8c-a52b-e053-2995a90a6df3	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1e79e1fa-3473-f4a7-e063-6294a90a9576	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tramadol hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	d7e75fd3-18d1-4370-bb63-c9dd8a2c1719	2025-01-01	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