Application 078604

Type: ANDA
Sponsor: INVAGEN 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
A078604-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11
A078604-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11
A078604-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078604-001	AB
A078604-002	AB
A078604-003	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	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`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	A078604-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078604-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram Oxalate	ESCITALOPRAM	REMEDYREPACK INC.	4508226c-5623-41d3-8916-5f94ffdb8839	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604
Escitalopram Oxalate	ESCITALOPRAM	Legacy Pharmaceutical Packaging, LLC	9c68f89b-1d34-4735-9631-817f012935d7	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604 ndc (product): 68645-519 ndc (product): 68645-520
Escitalopram Oxalate	ESCITALOPRAM	Cipla USA Inc.	31ce0b82-58fe-44f3-8887-c55d8df1b773	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604 ndc (product): 69097-847 ndc (product): 69097-849 ndc (product): 69097-848
Escitalopram oxalate	ESCITALOPRAM	Exelan Pharmaceuticals Inc.	8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604 ndc (product): 76282-249 ndc (product): 76282-250 ndc (product): 76282-251
Escitalopram oxalate	ESCITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	900b7a2f-23e7-4c78-bd6e-549bbe09883e	2021-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604 ndc (product): 71610-534

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-249	Escitalopram	Escitalopram	Camber Pharmaceuticals	ANDA	Current
31722-250	Escitalopram	Escitalopram	Camber Pharmaceuticals	ANDA	Current
31722-251	Escitalopram	Escitalopram	Camber Pharmaceuticals	ANDA	Current
53217-167	Escitalopram	Escitalopram	Aidarex Pharmaceuticals LLC	ANDA	Current
64725-0250	Escitalopram	Escitalopram	TYA Pharmaceuticals	ANDA	Current
64725-0251	Escitalopram	Escitalopram	TYA Pharmaceuticals	ANDA	Current
68645-519	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-519	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-519	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-519	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-519	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-520	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-520	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-520	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-520	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-520	Escitalopram Oxalate	Escitalopram	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
69097-847	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-847	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-847	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-847	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-847	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-848	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-848	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-848	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-848	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-848	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-849	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-849	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-849	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-849	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
69097-849	Escitalopram Oxalate	Escitalopram	Cipla USA Inc.	ANDA	Current
70518-3151	Escitalopram Oxalate	Escitalopram	REMEDYREPACK INC.	ANDA	Current
70518-3151	Escitalopram Oxalate	Escitalopram	REMEDYREPACK INC.	ANDA	Current
71610-534	Escitalopram oxalate	escitalopram	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-249	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-249	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-249	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-249	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-250	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-250	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-250	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-250	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-251	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-251	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-251	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-251	Escitalopram oxalate	escitalopram	Exelan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9172	ORIG	2011-05-10