Application 205619

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	TABLET;ORAL	EQ 5MG BASE	No	No
002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	TABLET;ORAL	EQ 10MG BASE	No	No
003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	TABLET;ORAL	EQ 20MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205619-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17
A205619-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17
A205619-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205619-001	AB
A205619-002	AB
A205619-003	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 4 · 126 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	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205619-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2017-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205619-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2017-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205619-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2017-05-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A205619-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205619-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205619-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205619-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205619-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205619-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205619-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205619-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205619-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205619-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205619-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205619-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205619-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205619-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205619-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205619-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205619-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205619-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205619-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205619-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205619-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205619-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205619-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205619-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205619-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205619-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205619-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205619-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205619-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205619-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205619-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205619-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205619-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205619-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205619-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205619-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205619-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205619-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205619-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205619-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Amneal Pharmaceuticals of New York LLC	4f941d7a-5abb-4907-a7a1-480245deef87	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205619 application number: ANDA205619
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Amneal Pharmaceuticals LLC	8704d062-fa91-4224-9dec-41664d20ee6b	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205619 application number: ANDA205619 ndc (product): 65162-021 ndc (product): 65162-019 ndc (product): 65162-020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-019	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-019	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-019	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-020	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-020	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-020	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-021	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-021	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-021	Escitalopram Oxalate	Escitalopram Oxalate	Amneal Pharmaceuticals LLC	ANDA	Current