Application 077289

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	TABLET;ORAL	EQ 10MG BASE	No	No
002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	TABLET;ORAL	EQ 20MG BASE	No	No
003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	TABLET;ORAL	EQ 40MG 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
A077289-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2006-11-30
A077289-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2006-11-30
A077289-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2006-11-30

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077289-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-11-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077289-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077289-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077289-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077289-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077289-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077289-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077289-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077289-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077289-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077289-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077289-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077289-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077289-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077289-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077289-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077289-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077289-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	75f6db65-e4ed-470a-9e56-12791f22ee9b	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077289 application number: ANDA077289 ndc (product): 43063-063
Citalopram	CITALOPRAM	Amneal Pharmaceuticals LLC	6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a	2024-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077289 application number: ANDA077289 ndc (product): 65162-052 ndc (product): 65162-053 ndc (product): 65162-054

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-063	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-063	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-063	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-063	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-063	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-063	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-385	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-385	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-385	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-385	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-385	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-385	Citalopram	Citalopram	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
49999-654	Citalopram	Citalopram	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-2732	Citalopram	Citalopram	A-S Medication Solutions	ANDA	Current
53401-200	Citalopram	Citalopram	Aphena Pharma Solutions - New Jersey, LLC	ANDA	Current
53401-201	Citalopram	Citalopram	Aphena Pharma Solutions - New Jersey, LLC	ANDA	Current
53401-202	Citalopram	Citalopram	Aphena Pharma Solutions - New Jersey, LLC	ANDA	Current
53808-1077	Citalopram	Citalopram	State of Florida DOH Central Pharmacy	ANDA	Current
61919-288	CITALOPRAM	CITALOPRAM	DIRECT RX	ANDA	Current
65162-052	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-052	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-052	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-052	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-052	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-052	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-052	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-053	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-053	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-053	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-053	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-053	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-053	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-053	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-054	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-054	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-054	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-054	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-054	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-054	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
65162-054	Citalopram	Citalopram	Amneal Pharmaceuticals LLC	ANDA	Current
67046-107	Citalopram	Citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-108	Citalopram	Citalopram	Contract Pharmacy Services-PA	ANDA	Current
67046-109	Citalopram	Citalopram	Contract Pharmacy Services-PA	ANDA	Current
68071-3034	Citalopram	Citalopram	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3034	Citalopram	Citalopram	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3034	Citalopram	Citalopram	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6810	Citalopram	Citalopram	Preferred Pharmaceuticals Inc.	ANDA	Current