Application 077040

Type: ANDA
Sponsor: FOSUN PHARMA

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 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
A077040-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17
A077040-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17
A077040-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17

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	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077040-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2005-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077040-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2005-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077040-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2005-08-17	`301d65b070ca…`

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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM HYDROBROMIDE	Aphena Pharma Solutions - Tennessee, LLC	31ddd184-7560-473c-b674-5fa3187c5598	2020-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	289c1d5e-902f-47db-85b8-5e1a55ec8684	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	d05f4e71-95f3-4f22-8b01-b21e5c19e0f2	2018-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CITALOPRAM HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.