Application 078053

Type: ANDA
Sponsor: RANBAXY LABS LTD

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 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
A078053-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL			2007-02-05

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078053-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	2007-02-05	`f41ea6bd6efb…`

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 5 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	23f1c8c5-032c-4ea9-beb0-ca3a614ba4b6	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b94d67-0000-a045-e063-6394a90ade32	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	680890b1-bc45-4f50-9aaf-e730ab515b85	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Asclemed USA, Inc.	e25a13c3-a173-4cc3-99d3-0be43abbc498	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	2ce05049-030f-3e8b-e063-6394a90a4885	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	DIRECT RX	ab962a5a-fff6-2cf9-e053-2995a90ace0f	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	c4bad433-623b-402c-b454-d39f19a23627	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0e5a7b02-3972-47f0-9f49-e958d792beac	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae3be25b-2bde-4142-ad56-920a96ac8f39	2025-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	ec1b68d3-ff55-d0a2-e053-2a95a90a2e0b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8c45a99-18ed-0e1f-e053-6394a90a2d52	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Quality Care Products LLC	25aef6c1-9964-44a1-a905-c37e5c28a3c0	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	American Health Packaging	4e09f580-d612-416c-a4a4-79a4411845b2	2024-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	f705f743-40e9-42bf-88f5-6dd7e5d5ba94	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	4f6f2412-8085-45bf-be4f-63e44490a34e	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9f1d5689-3bf1-431c-9ea2-9e37217ecf40	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	4191b929-5bdb-4388-9e4d-fffce55bc363	2024-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1a58062b-e635-431a-908d-2651c6a4a21c	2024-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	de1f85ac-df1b-4b7b-8e18-48ebdc8b9279	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	fa260c6c-9f6a-46a3-91ce-5665739d87e7	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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