Application 078766

Type: ANDA
Sponsor: HIKMA 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 43.

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
A078766-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11
A078766-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11
A078766-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078766-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078766-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078766-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078766-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078766-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078766-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078766-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078766-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078766-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078766-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078766-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078766-003	AB	1	`ea99ee380514…`

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITALOPRAM OXALATE	American Health Packaging	3019a647-9bcf-48cf-928c-0467f9b921a8	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	NCS HealthCare of KY, LLC dba Vangard Labs	b29ae169-d60b-464a-9763-f1d8d9e0598d	2025-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
escitalopram oxalate	ESCITALOPRAM OXALATE	Bryant Ranch Prepack	86cfcd96-6397-42ef-8a79-f62706f0aca6	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: escitalopram oxalate generic name: ESCITALOPRAM OXALATE
escitalopram oxalate	ESCITALOPRAM OXALATE	Quallent Pharmaceuticals Health LLC	d8e22060-4d06-42bf-a881-caaf65ecc3e3	2024-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: escitalopram oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Amneal Pharmaceuticals of New York LLC	4f941d7a-5abb-4907-a7a1-480245deef87	2024-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Amneal Pharmaceuticals LLC	8704d062-fa91-4224-9dec-41664d20ee6b	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	A-S Medication Solutions	76993020-6715-4090-847e-0fdcc5328f31	2024-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	A-S Medication Solutions	c980262b-31f0-46df-902d-e593e1557fef	2024-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram Oxalate	ESCITALOPRAM OXALATE	NorthStar RxLLC	81840aec-96fd-4af2-bd10-3f38d068f39a	2024-07-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram oxalate	ESCITALOPRAM	Exelan Pharmaceuticals Inc.	8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram oxalate
Escitalopram Oxalate	ESCITALOPRAM OXALATE	Macleods Pharmaceuticals Limited	24b43cb4-1a26-44a2-b1d8-a40239eb5c7c	2024-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram Oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	A-S Medication Solutions	b85ef018-0217-4ddf-885d-206acc0a5f84	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Advanced Rx Pharmacy of Tennessee, LLC	138f8703-2f13-6d07-e063-6394a90a4413	2024-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	NCS HealthCare of KY, LLC dba Vangard Labs	ac9ede0c-7912-4e7d-83b3-964feee61215	2023-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	A-S Medication Solutions	10b25a10-c5e7-479b-a9f5-7eeafd802323	2023-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
escitalopram oxalate	ESCITALOPRAM OXALATE	Proficient Rx LP	8201a719-7837-45fb-b991-4fcdbf006d24	2023-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: escitalopram oxalate generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Proficient Rx LP	52df055d-b1c8-4de2-8545-ef08b5bf9c39	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram	ESCITALOPRAM OXALATE	Proficient Rx LP	2d0b4839-e4d1-4e0e-9dc0-ba821f266472	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ESCITALOPRAM OXALATE
Escitalopram oxalate	ESCITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	900b7a2f-23e7-4c78-bd6e-549bbe09883e	2021-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Escitalopram oxalate
escitalopram oxalate	ESCITALOPRAM OXALATE	Proficient Rx LP	e773030f-d07d-4bb8-9dc9-6f649688346d	2020-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: escitalopram oxalate generic name: ESCITALOPRAM OXALATE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9807	Escitalopram	Escitalopram	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9808	Escitalopram	Escitalopram	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9809	Escitalopram	Escitalopram	West-Ward Pharmaceuticals Corp	ANDA	Current
43063-389	Escitalopram	Escitalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-390	Escitalopram	Escitalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
59115-100	Escitalopram	Escitalopram	Hikma Pharmaceutical	ANDA	Current
59115-100	Escitalopram	Escitalopram	Hikma Pharmaceutical	ANDA	Current
59115-101	Escitalopram	Escitalopram	Hikma Pharmaceutical	ANDA	Current
59115-101	Escitalopram	Escitalopram	Hikma Pharmaceutical	ANDA	Current
59115-102	Escitalopram	Escitalopram	Hikma Pharmaceutical	ANDA	Current
59115-102	Escitalopram	Escitalopram	Hikma Pharmaceutical	ANDA	Current
68258-7128	Escitalopram	Escitalopram	Dispensing Solutions, Inc.	ANDA	Current