Application 077512

Type: ANDA
Sponsor: PHARM ASSOC

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 1.

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	Approval date
A077512-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12
A077512-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12
A077512-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077512-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077512-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077512-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077512-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077512-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077512-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077512-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077512-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077512-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077512-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077512-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077512-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077512-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077512-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077512-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077512-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077512-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077512-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077512-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077512-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077512-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077512-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077512-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077512-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077512-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077512-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077512-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077512-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077512-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077512-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077512-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077512-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077512-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077512-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077512-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077512-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077512-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077512-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077512-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077512-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077512-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077512-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077512-001	AB	1	`6a51e52b5d6a…`

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 2 · 40 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	Name fallback brand name: Escitalopram Oxalate
Escitalopram	ESCITALOPRAM OXALATE	PD-Rx Pharmaceuticals, Inc.	517a551a-6f60-4b8d-9341-63a41baff12d	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Jubilant Cadista Pharmaceuticals Inc.	2db02476-325f-ee47-a7e5-b5aed56c364c	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Bryant Ranch Prepack	ee5963ad-3b53-48e5-b7a9-b13af5740ef1	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	St. Mary's Medical Park Pharmacy	09945404-e4cf-6269-e063-6294a90a5b8d	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Camber Pharmaceuticals, Inc.	82d793ee-4039-45fc-ac83-4bd5235f00aa	2026-05-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Rising Pharma Holdings, Inc.	79fddc2d-2dc2-444f-8fd3-0337090ee744	2026-05-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
escitalopram oxalate	ESCITALOPRAM OXALATE	Bryant Ranch Prepack	a3a158a3-43ee-4b08-8171-e8c0d6ed0e66	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: escitalopram oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Aurobindo Pharma Limited	d5fbc8ce-bd41-4bd0-b413-0dea97e596c3	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Aurobindo Pharma Limited	ba60c357-8e61-4a3d-b1dc-25602dbbfc2a	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
escitalopram oxalate	ESCITALOPRAM OXALATE	Preferred Pharmaceuticals Inc.	7d924d16-8a10-411d-be57-97c450f56de7	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: escitalopram oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM	Legacy Pharmaceutical Packaging, LLC	9c68f89b-1d34-4735-9631-817f012935d7	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate
Escitalopram	ESCITALOPRAM OXALATE	Asclemed USA, Inc.	2957a003-7714-4e16-aeca-623fd6c5d702	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Northwind Health Company, LLC	f6ca64ec-68ff-e1ea-e053-6294a90ae0f8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	QPharma, Inc.	85fbcce8-a870-4f04-8a0e-a12e46eed3cf	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
escitalopram oxalate	ESCITALOPRAM OXALATE	PD-Rx Pharmaceuticals, Inc.	b7670e51-8f44-4f64-b110-3f2f431a4032	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: escitalopram oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM	Cipla USA Inc.	31ce0b82-58fe-44f3-8887-c55d8df1b773	2025-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate
ESCITALOPRAM OXALATE	ESCITALOPRAM	Ascent Pharmaceuticals, Inc	1285841d-d9f8-49c6-9456-bf51c8e37271	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Sun Pharmaceutical Industries, Inc.	c871d3fe-5ca2-410c-976d-9ec4b72c878f	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM	Amneal Pharmaceuticals LLC	09894a38-4e3a-475d-96cd-c6c8ed87869a	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54879-009	escitalopram	escitalopram	STI Pharma LLC	ANDA	Current
54879-010	escitalopram	escitalopram	STI Pharma LLC	ANDA	Current
54879-011	escitalopram	escitalopram	STI Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31254	ORIG	2011-05-10