Application 078777

Type: ANDA
Sponsor: GRAVITI 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
A078777-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11
A078777-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11
A078777-003	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
A078777-001	AB
A078777-002	AB
A078777-003	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	A078777-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078777-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078777-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078777-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078777-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078777-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078777-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078777-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078777-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	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	A078777-001	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	A078777-002	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	A078777-003	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	A078777-001	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	A078777-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078777-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078777-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078777-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078777-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078777-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078777-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078777-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078777-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078777-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078777-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078777-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078777-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078777-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078777-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078777-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078777-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078777-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078777-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078777-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078777-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078777-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078777-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078777-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078777-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078777-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078777-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078777-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078777-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078777-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078777-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078777-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078777-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078777-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078777-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078777-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078777-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078777-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078777-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078777-001	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
escitalopram	ESCITALOPRAM	St. Mary's Medical Park Pharmacy	1b2ec266-be5b-9265-e063-6294a90a10e3	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	REMEDYREPACK INC.	76a8aedd-7853-4d3f-9a00-f8222f55bea8	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Preferred Pharmaceuticals Inc.	eef1c681-1972-4c3f-b4ba-cbb3388f397a	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Preferred Pharmaceuticals Inc.	d16a7510-c787-4c9b-818b-1ffbcc62b3c3	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	64de12e0-c35f-4082-b902-ddbaee8158a6	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	REMEDYREPACK INC.	d75e3b97-1ead-4e7b-9ae3-3626aede1efd	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	REMEDYREPACK INC.	53a7e974-9945-4e42-8395-b567bf9f1c4e	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	ST. MARY'S MEDICAL PARK PHARMACY	362327ce-2dde-f657-e063-6394a90a0b63	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	A-S Medication Solutions	3965ca55-a5ff-4ed0-940c-363d74683fab	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Coupler LLC	2d54a1cf-29cd-c485-e063-6394a90aeba3	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Coupler LLC	2d58c448-4a6c-1b7d-e063-6294a90a7d03	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	3ca5da44-403b-4c9f-9dde-f5a87866836d	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	735a138b-fff3-4ed0-8a51-9090cf88ba30	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777
escitalopram	ESCITALOPRAM	Rising Pharma Holdings, Inc.	ccbe97b5-da68-4fff-929a-240dd705fe6f	2024-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078777 application number: ANDA078777

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
50436-0054	Escitalopram	Escitalopram Oxalate	Unit Dose Services	ANDA	Current
69844-033	ESCITALOPRAM	ESCITALOPRAM OXALATE	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-034	ESCITALOPRAM	ESCITALOPRAM OXALATE	Graviti Pharmaceuticals Private Limited	ANDA	Current
69844-035	ESCITALOPRAM	ESCITALOPRAM OXALATE	Graviti Pharmaceuticals Private Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31388	ORIG	2011-05-10