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HYDROBROMIDE	SOLUTION;ORAL	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 1.

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CELEXA	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1999-12-22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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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UTC	2026-02	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`011fe1cb6892…`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ZIP	2025-12	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`31067a03dcf5…`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UTC	2025-08	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`6a471c1ec25d…`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ZIP	2025-03	N021046-001	CELEXA	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1999-12-22	`fd3edfee7708…`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…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals Inc.	27ddea53-f03d-4760-99bb-ec8efa44ff62	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	625a78b2-4751-4ca5-91b6-7c85fd9f8c2e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals, Inc.	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	d9cc1649-913d-832d-e053-2995a90a5f9a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	d9ccb3fb-b607-9491-e053-2995a90a39c9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	c133fc77-6c8a-d2b1-e053-2995a90ab5f7	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	QPharma, Inc.	0a967468-3869-4c8c-849f-9fc3a8dcc489	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	31a18cdf-b0aa-18f5-e054-00144ff8d46c	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	544ba802-a536-579a-e054-00144ff88e88	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	ATLANTIC BIOLOGICALS CORP.	2640311d-8b88-4513-9c80-a08390b8142a	2025-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	0109f365-bebd-4810-a56f-4451e10245db	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	c577b306-ee7c-8364-e053-2a95a90abb13	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	c584909b-e7b2-7108-e053-2995a90a2f54	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8b06b55-f6a2-2438-e053-6394a90a530a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Quality Care Products, LLC	6fc110ba-87e7-404e-9e00-b680f354c7b0	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Quality Care Products, LLC	e22fe468-5d9e-4ec7-a69b-4988e0b8acbd	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	8719bd44-36b6-468d-9203-8c53a2645184	2024-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	1a136cc3-d655-4f3c-8710-2603dc008492	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	2500cc9d-a67d-46c5-9a76-99bc63959d67	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM HYDROBROMIDE

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