Application 021046

Type: NDA
Sponsor: FOREST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CELEXA	CITALOPRAM HYDROBROMIDE	SOLUTION;ORAL	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021046-001	CELEXA	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1999-12-22

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021046-001	CELEXA	EQ 10MG BASE/5ML	SOLUTION / ORAL	RLD	1999-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021046-001	CELEXA	EQ 10MG BASE/5ML	SOLUTION / ORAL	RLD	1999-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	1999-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`f41ea6bd6efb…`

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	15cb00da-4435-4930-90d0-faadf2739a5c	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	05421bee-f746-418e-bb9c-ab44a89b567d	2024-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	b244d4eb-8311-4663-8bca-dc08e88e5f5d	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals, Inc.	4f45c818-b324-6ca6-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	579836d8-64ed-de2d-e053-2a91aa0a8392	2024-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	549a5b3f-4928-1ae5-e054-00144ff8d46c	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	e0822069-9672-4d4c-bc1a-8739b0dd045c	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	9987a273-e6d7-54cd-e053-2a95a90a0aaa	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Aurobindo Pharma Limited	2632b547-2e13-447f-ac85-c774e437d6a8	2024-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Aurobindo Pharma Limited	e7a2cbdd-1bdb-4e59-a3dd-298a189753ae	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	fc766b76-18c1-42cd-b276-f720f5821c11	2024-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Camber Pharmaceuticals, Inc.	dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	c6730edc-7226-4521-a04a-1bf296b01b8d	2024-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	9059c8f1-8755-492d-aba2-5f5088ce69d3	2023-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	9d2f8f9f-9710-48e0-bc18-105a2af1073b	2023-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Celexa	CITALOPRAM	Allergan, Inc.	4259d9b1-de34-43a4-85a8-41dd214e9177	2023-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celexa
Citalopram	CITALOPRAM HYDROBROMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fd761647-e16b-45b3-a4bc-364de0ed7015	2023-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	4eb71151-241a-476e-a495-4a021bc55bda	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	f37cc307-8b7d-4e5c-8beb-cd8779bc86a7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44091	ORIG	2016-04-11
41904	SUPPL	2013-09-11
4164	SUPPL	2012-12-05
14246	SUPPL	2012-12-03
35980	SUPPL	2012-03-29
4163	SUPPL	2012-03-29
41903	SUPPL	2011-10-11
21389	SUPPL	2011-10-11
4162	SUPPL	2011-08-17
4161	SUPPL	2011-08-17
35979	SUPPL	2011-08-16
35978	SUPPL	2011-08-16
43698	ORIG	2009-11-16
14245	SUPPL	2009-02-04
26591	SUPPL	2009-02-03
35977	SUPPL	2008-09-19
26590	SUPPL	2008-09-19
26589	SUPPL	2007-08-07
35976	SUPPL	2007-08-03
4160	SUPPL	2005-02-23
4159	SUPPL	2004-05-26
4158	SUPPL	2004-04-20
4157	SUPPL	2002-11-19
26588	ORIG	1999-12-22
21388	ORIG	1999-12-22