Application 091607

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	Yes
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 44.

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
A091607-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30
A091607-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30
A091607-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2011-12-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2011-12-30	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

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	A091607-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-002	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-003	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091607-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-002	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-003	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091607-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-002	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-003	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091607-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-003	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091607-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-002	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-003	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091607-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-002	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-003	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-001	AB2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-002	AB2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-003	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091607-001	AB2	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-002	AB2	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-003	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091607-001	AB2	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-002	AB2	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-003	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091607-001	AB2	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091607-002	AB2	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091607-003	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091607-001	AB2	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091607-002	AB2	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091607-003	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091607-001	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091607-002	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091607-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091607-001	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091607-002	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091607-003	AB2	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091607-001	AB2	1	`a67488948f0b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	dc420d50-6192-482d-b3da-3be55870a79a	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091607 application number: ANDA091607 ndc (product): 47335-533 ndc (product): 47335-537 ndc (product): 47335-531
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	bba287fe-fbf6-65a9-e053-2a95a90a9237	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091607 application number: ANDA091607 ndc (product): 80425-0127

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-531	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-531	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-531	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-531	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-531	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-533	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-533	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-533	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-533	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-533	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-537	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-537	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-537	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-537	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-537	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50436-0824	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Unit Dose Services	ANDA	Current
50436-8788	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Unit Dose Services	ANDA	Current
80425-0127	Conzip	Tramadol 200mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0127	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0127	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0127	Tramadol HCL	Tramadol HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76049	ORIG	2023-11-02
43253	ORIG	2012-02-14
31543	ORIG	2012-02-14