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 7 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	A-S Medication Solutions	286b429d-62b9-4ca8-a243-de3f619315bf	2023-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
sertraline HCl	SERTRALINE HYDROCHLORIDE	Almatica Pharma LLC	8c8bcba9-eaeb-aa44-f9ea-b580de55a439	2023-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SERTRALINE HYDROCHLORIDE
Zoloft	SERTRALINE HYDROCHLORIDE	Viatris Specialty LLC	fda754f6-d0f3-4dce-a17a-927d64f912f7	2023-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	5b73a90e-b883-419b-b30f-a379eed764d9	2023-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	14c4fa96-8919-4ea7-ad72-129f288d8cfc	2023-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	513ecb5b-062f-455f-b798-1c9a54222ff3	2023-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	0f264823-1cba-4478-aef1-a8587f221dbb	2022-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	68c94fb4-3018-44af-b982-2b4b6d461e6f	2022-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	ba201164-f6f7-4779-87a3-62780f332113	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	a0b4b9c9-bd5b-4900-8abf-b55d3283c53c	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Ascent Pharmaceuticals, Inc.	056191ca-999a-4c9b-93b9-64db44b8e628	2021-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e815c67d-951c-4cb3-a840-f0b493b97da1	2020-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	787a683a-091c-4908-a643-ecbc8fd467eb	2020-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	00179766-980b-44b0-99d3-1fee2bb27e37	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	551d5946-00df-4608-96a2-b29f0ef93ba0	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	6b532e6a-b040-4a10-a242-fb6d8dfc0852	2019-11-01	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.