Application 215133

Type: NDA
Sponsor: ALMATICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZERCAPLI	SERTRALINE HYDROCHORIDE	CAPSULE; ORAL	150MG	No	No
002	ZERCAPLI	SERTRALINE HYDROCHORIDE	CAPSULE; ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215133-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2021-10-04
N215133-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2021-10-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N215133-001	AB
N215133-002	AB

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 · 72 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
2026-10-15 13:18:30	2026-09	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2021-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2021-10-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2021-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2021-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2021-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2021-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2021-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2021-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2021-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2021-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2021-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD	2021-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215133-001	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		RLD	2021-10-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N215133-002	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2021-10-04	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N215133-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215133-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215133-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215133-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215133-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215133-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215133-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215133-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215133-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215133-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215133-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215133-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215133-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215133-002	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Alvogen, Inc.	e0e1f35e-114d-bb39-34f1-70208b94ac9e	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215133 application number: NDA215133

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52427-664	sertraline HCl	sertraline hydrochloride	Almatica Pharma LLC	NDA	Current
52427-664	sertraline HCl	sertraline hydrochloride	Almatica Pharma LLC	NDA	Current
52427-672	sertraline HCl	sertraline hydrochloride	Almatica Pharma LLC	NDA	Current
52427-672	sertraline HCl	sertraline hydrochloride	Almatica Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75249	SUPPL	2023-08-22
75187	SUPPL	2023-08-21
75186	SUPPL	2023-08-21
71421	ORIG	2022-06-22
71420	ORIG	2022-06-22
68888	ORIG	2021-10-05
68887	ORIG	2021-10-05
68884	ORIG	2021-10-05