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 4 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	Cranbury Pharmaceuticals, LLC	1d4af58f-17f3-4cbd-870c-098ace954872	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4ea18b0-2cbd-0d42-e053-2995a90a9264	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	f79fda81-f09a-4a08-babc-6bd3bb3ee661	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	68484531-f908-473f-a422-f37234de9691	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	7e421fb6-737c-49b3-b299-50511e281a4d	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27460cc6-0782-7838-e063-6394a90a19f1	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	6ebc5864-c222-4400-a9b2-f66fd6fb0da6	2024-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tramadol hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HCL ER	TRAMADOL HCL	DIRECT RX	5285f056-c32c-4e7a-bec6-3a726aa23d5a	2024-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	1cd3caee-bf54-7aba-e063-6394a90ad8cb	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tramadol hydrochloride generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f44c53ec-26ea-d272-e053-2a95a90a5e59	2024-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	8cc09b31-6067-44ec-8aba-ea7bb1a1f448	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	b2f3f007-6dda-4532-9f7f-d93f6e65254c	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	93c9c960-afbf-6d3d-e053-2995a90a8d15	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	2236031d-8596-4c21-8b16-83aa3e4122c1	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tramadol hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	93e129c8-64c4-1f6d-e053-2a95a90ac1f8	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	e90d4ef3-8b90-41b7-bf96-340852e89b5f	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Medsource Pharmaceuticals	1278980b-4068-df57-e063-6394a90a8742	2024-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3e0ccb95-3e8e-477c-b4d2-6060ee05f930	2023-12-11	Warnings, Adverse reactions	Name fallback brand name: Tramadol Hydrochloride generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	2023-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAMADOL HYDROCHLORIDE generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	TruPharma, LLC	aea56ff9-94ac-47a8-8f15-8790d538973b	2023-01-25	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