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 2 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	Unit Dose Solutions, Inc.	55f514c6-f6ec-13ac-e063-6294a90ac957	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9c0a7f78-9cac-4e82-b971-f3f9758f8a0c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	575da603-b038-421f-9894-6796d9ac33cc	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Northwind Health Company, LLC	4ddfd698-3d47-fc0e-e063-6394a90accec	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	544d1ed1-da06-976d-e063-6394a90afe79	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	e919f195-0ce1-4d71-9883-efec05b9a050	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	8d444aec-cf33-b769-e053-2995a90a54be	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	730448bf-2d78-44a4-e053-2991aa0ada9e	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	5e91adad-9757-49e4-a3f1-1db0ef396416	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	aa13261f-46a7-4381-8084-b3ad46221e2f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	1fcd3f6d-a71f-b131-e063-6394a90a4b26	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	518caa95-2cd7-a293-e063-6394a90adbd0	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	7f81de84-0ad7-f050-e053-2a91aa0aa762	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	5103d12c-9453-a855-e063-6294a90a6f0c	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	cac718b8-64bc-4aca-9b22-f2b00077bd41	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	268bd7f7-bc17-4850-ab7c-1b73caa564d5	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	4f94a6d7-8719-834c-e063-6294a90a3448	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	6c26a87a-b2b6-4302-bb8d-2031461f28ce	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	98960cc1-1d44-4d89-b415-7e250cc762cc	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	ddbf623f-8b6f-4e8d-87d3-dc890c0ab875	2026-03-30	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.