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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075982-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-07-01	`cb3db0bc1861…`

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 2 of 5 · 92 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	a886d551-6b57-4d9d-87f4-e1366385c7fd	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tramadol hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	b5852b90-e415-47ef-8f73-87266b58e033	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	4a525cf7-2c0c-47c6-aed3-3a395a7120ec	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	f9282800-fde7-477a-8b8f-59617ec26f73	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	18d9e3e4-5892-43b8-b211-3ef3393ad946	2026-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	24aea499-c6f1-9200-e063-6394a90a9db6	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride Extended-Release	TRAMADOL HYDROCHLORIDE	Trigen Laboratories, LLC	c0bc7218-3fd0-4646-96f4-25355fc84aa9	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advagen Pharma Limited	93b12089-3a0f-4b57-abb1-2429cf31995d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	8ec4e4e5-a56e-4198-8428-6b770b9bf27d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	561f00e5-f69c-4369-ae4d-5eff86c4499f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
ConZip	TRAMADOL HYDROCHLORIDE	Vertical Pharmaceuticals, LLC	a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Northwind Health Company, LLC	1b5360f8-3e95-a047-e063-6294a90a7315	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tramadol hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3d719560-7449-f970-e063-6294a90a9bd8	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	a07ed444-54e4-4d45-b6a1-6ea2f6dedc61	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	dc420d50-6192-482d-b3da-3be55870a79a	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	004de5a4-80f8-4040-a6ea-be5e99352a36	2025-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
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

Documents#

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