Application 078861

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	CONCENTRATE;ORAL	EQ 20MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078861-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA		2008-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078861-001	AA

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 · 42 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
2026-08-18 06:07:40	2026-07	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078861-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2008-10-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078861-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078861-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078861-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078861-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078861-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078861-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078861-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078861-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078861-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078861-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078861-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078861-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078861-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078861-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078861-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078861-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078861-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078861-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078861-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078861-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078861-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078861-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078861-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078861-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078861-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078861-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078861-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078861-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078861-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078861-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078861-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078861-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078861-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078861-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078861-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078861-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078861-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078861-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078861-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078861-001	AA	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NorthStar Rx LLC	7f144b68-ae90-483c-b030-f6824662a734	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078861 application number: ANDA078861 ndc (product): 16714-601
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	af2c75a3-131e-4bde-83fd-310fd2c01161	2024-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078861 application number: ANDA078861 ndc (product): 64980-409
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aurobindo Pharma Limited	01800452-c353-4235-a66a-214048752e74	2024-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078861 application number: ANDA078861 ndc (product): 65862-224

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-601	Sertraline Hydrochloride	Sertraline Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-601	Sertraline Hydrochloride	Sertraline Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-601	Sertraline Hydrochloride	Sertraline Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-601	Sertraline Hydrochloride	Sertraline Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-601	Sertraline Hydrochloride	Sertraline Hydrochloride	NorthStar Rx LLC	ANDA	Current
64980-409	Sertraline Hydrochloride	Sertraline Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-409	Sertraline Hydrochloride	Sertraline Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-409	Sertraline Hydrochloride	Sertraline Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-409	Sertraline Hydrochloride	Sertraline Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
65862-224	Sertraline Hydrochloride	Sertraline Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-224	Sertraline Hydrochloride	Sertraline Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-224	Sertraline Hydrochloride	Sertraline Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-224	Sertraline Hydrochloride	Sertraline Hydrochloride	Aurobindo Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44396	ORIG	2008-11-25