Application 215428

Type: NDA
Sponsor: ALMATICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CITALOPRAM	CITALOPRAM	CAPSULE; ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N215428-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL	AB	RLD, RS	2022-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N215428-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL	AB	RLD, RS	2022-01-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL	AB	RLD, RS	2022-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL	AB	RLD, RS	2022-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL		RLD, RS	2022-01-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215428-001	CITALOPRAM HYDROBROMIDE	EQ 30MG BASE	CAPSULE / ORAL	AB	RLD, RS	2022-01-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N215428-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215428-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215428-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215428-001	AB	1	`a50c72e98297…`

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 4 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	2500cc9d-a67d-46c5-9a76-99bc63959d67	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM	Bryant Ranch Prepack	2a8acad8-0ba0-4631-9f6d-f587e7a8558c	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	Amneal Pharmaceuticals LLC	6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a	2024-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
CITALOPRAM	CITALOPRAM	Epic Pharma, LLC	08b6d5da-5919-4760-9e16-3b478a14d6d7	2024-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CITALOPRAM generic name: CITALOPRAM
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	b244d4eb-8311-4663-8bca-dc08e88e5f5d	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM	Cipla USA Inc.	0580559a-783a-4a0a-8d81-ee30a29077c5	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Exelan Pharmaceuticals Inc.	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM
Citalopram	CITALOPRAM HYDROBROMIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	e0822069-9672-4d4c-bc1a-8739b0dd045c	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM	Mylan Pharmaceuticals Inc.	825c0c49-5fbf-6d8b-cb8c-94ebf0eda043	2024-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM HYDROBROMIDE	Aurobindo Pharma Limited	2632b547-2e13-447f-ac85-c774e437d6a8	2024-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM	A-S Medication Solutions	c91684c7-fddb-4cf0-9711-b0484c8c7e8b	2024-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	A-S Medication Solutions	17af7a8d-ef57-4253-96ed-e457e0062eb5	2024-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	A-S Medication Solutions	04ac5286-fc2e-4990-a574-ea21131ef731	2024-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	fc766b76-18c1-42cd-b276-f720f5821c11	2024-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	c6730edc-7226-4521-a04a-1bf296b01b8d	2024-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM	NuCare Pharmaceuticals,Inc.	0dfb11d9-f48d-56ee-e063-6294a90ad256	2024-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Celexa	CITALOPRAM	Allergan, Inc.	4259d9b1-de34-43a4-85a8-41dd214e9177	2023-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CITALOPRAM
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 brand name: Citalopram
Citalopram	CITALOPRAM	Hikma Pharmaceuticals USA Inc.	29408d84-7b00-4cee-969c-8095f8083ff5	2023-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	Hahnemann Laboratories, INC.	e0cc472a-dbab-71c3-e053-2995a90adf50	2022-06-06		Name fallback brand name: Citalopram generic name: CITALOPRAM

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52427-691	citalopram	citalopram	Almatica Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75248	SUPPL	2023-08-22
75189	SUPPL	2023-08-21
75188	SUPPL	2023-08-18
72479	ORIG	2022-10-26
70057	ORIG	2022-02-03
70056	ORIG	2022-02-03
70042	ORIG	2022-02-01