Application 201384

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No
003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201384-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07
A201384-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07
A201384-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07

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 4 · 123 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	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201384-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201384-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201384-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201384-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201384-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201384-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201384-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201384-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201384-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201384-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201384-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201384-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201384-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201384-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201384-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201384-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201384-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201384-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201384-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201384-001	AB1	1	`87673890dc5c…`

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 · 10 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	66359f41-9999-4cb8-b632-1fe2ec1e60b2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 71335-1676
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	43fe10b2-17a4-4dc2-9a48-2378547b61fd	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 71335-1675
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	a77b0dba-8ac7-418a-b435-16a0e6c22804	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 63629-8324
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	004de5a4-80f8-4040-a6ea-be5e99352a36	2025-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 47335-859 ndc (product): 47335-861 ndc (product): 47335-860
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	c197f4e4-9ea5-562b-e053-2a95a90a975c	2024-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 80425-0141
TRAMADOL HCL ER	TRAMADOL HCL	DIRECT RX	5285f056-c32c-4e7a-bec6-3a726aa23d5a	2024-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 61919-893
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	00b7f61b-5173-43e6-a3f9-d2efbda40c19	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 71205-708
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	dce0d21e-e4c2-4875-a2ce-9d53df190b80	2022-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 76420-244 ndc (product): 76420-246 ndc (product): 76420-245
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	27495d02-8641-4c92-b5a3-edf50abc2a6f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 63187-597
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	68646295-49b2-45ac-bf19-99bb91f7333d	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 71205-656

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 77 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-790	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-790	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-790	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
45865-876	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	medsource pharmaceuticals	ANDA	Current
45865-900	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	medsource pharmaceuticals	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-859	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-860	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-861	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50090-2215	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-6033	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
55700-016	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-016	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-016	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-029	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-029	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-029	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products LLC	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-892	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DirectRX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-893	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-597	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63187-597	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63187-597	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63629-8324	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-8324	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-8324	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
68071-2648	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2732	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7373	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals	ANDA	Current
68788-7762	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7762	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7762	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7763	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7763	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7763	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8921	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9232	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals	ANDA	Current
68788-9237	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals	ANDA	Current
70518-3386	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3397	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3418	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
71205-656	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71205-708	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
71335-1675	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1675	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1675	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1676	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1676	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1676	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
76420-244	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76420-245	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76420-246	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76519-1132	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	H. J. Harkins Company Inc.	ANDA	Current
76519-1142	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	H.J. Harkins Company, Inc.	ANDA	Current
80425-0141	Ultram	Tramadol 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Ultram	Tramadol 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0141	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76067	ORIG	2023-11-02