Application 078169

Type: ANDA
Sponsor: LUPIN LTD

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
A078169-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11
A078169-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11
A078169-003	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
A078169-001	AB
A078169-002	AB
A078169-003	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	A078169-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078169-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078169-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078169-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078169-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078169-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078169-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078169-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078169-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	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	A078169-001	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	A078169-002	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	A078169-003	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	A078169-001	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	A078169-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078169-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078169-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078169-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078169-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078169-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078169-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078169-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078169-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078169-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078169-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078169-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078169-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078169-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078169-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078169-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078169-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078169-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078169-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078169-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078169-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078169-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078169-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078169-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078169-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078169-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078169-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078169-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078169-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078169-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078169-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078169-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078169-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078169-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078169-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078169-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078169-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITSLOPRAM	Lupin Pharmaceuticals, Inc.	41f7392a-1f5c-4542-9c5c-f9e109851381	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078169 application number: ANDA078169 ndc (product): 68180-137 ndc (product): 68180-135 ndc (product): 68180-136

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7953	Escitalopram	Escitslopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7953	Escitalopram	Escitslopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7954	Escitalopram	Escitslopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7954	Escitalopram	Escitslopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7955	Escitalopram	Escitslopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7955	Escitalopram	Escitslopram	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50090-5703	Escitalopram	Escitslopram	A-S Medication Solutions	ANDA	Current
50090-5704	Escitalopram	Escitslopram	A-S Medication Solutions	ANDA	Current
50090-5705	Escitalopram	Escitslopram	A-S Medication Solutions	ANDA	Current
50090-5830	Escitalopram	Escitslopram	A-S Medication Solutions	ANDA	Current
50090-5831	Escitalopram	Escitslopram	A-S Medication Solutions	ANDA	Current
50090-5831	Escitalopram	Escitslopram	A-S Medication Solutions	ANDA	Current
63629-6425	Escitalopram	Escitslopram	Bryant Ranch Prepack	ANDA	Current
63629-6425	Escitalopram	Escitslopram	Bryant Ranch Prepack	ANDA	Current
68180-135	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-135	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-135	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-135	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-135	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-136	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-136	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-136	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-136	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-136	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-137	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-137	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-137	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-137	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-137	Escitalopram	Escitslopram	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-2362	Escitalopram	Escitslopram	REMEDYREPACK INC.	ANDA	Current
70518-2362	Escitalopram	Escitslopram	REMEDYREPACK INC.	ANDA	Current
70518-2362	Escitalopram	Escitslopram	REMEDYREPACK INC.	ANDA	Current
70518-2362	Escitalopram	Escitslopram	REMEDYREPACK INC.	ANDA	Current
70518-2521	Escitalopram	Escitslopram	REMEDYREPACK INC.	ANDA	Current