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 1 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	0109f365-bebd-4810-a56f-4451e10245db	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	625a78b2-4751-4ca5-91b6-7c85fd9f8c2e	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram
Citalopram	CITALOPRAM	REMEDYREPACK INC.	f79f878e-99fb-4757-8abb-931af1fa9e2b	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	REMEDYREPACK INC.	aa9c1440-354f-43a6-9e70-fd7bafcb03c5	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	REMEDYREPACK INC.	c9809dfe-939e-4f9d-b6dd-f9808fd9f2b1	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	REMEDYREPACK INC.	25b0d184-2a4c-42b0-9a57-7a00fa3e0cd7	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	9fe40d83-8945-4577-add5-28d52410154e	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	St. Mary's Medical Park Pharmacy	db900453-4777-4142-a236-5d3a6152d0a5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	Coupler LLC	53e5d66f-7902-76ac-e063-6294a90aa526	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	Coupler LLC	53e6d0a4-95d9-9c1a-e063-6294a90a9d18	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	Bryant Ranch Prepack	9b53c14c-224c-49ed-8a00-96f871593ab0	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	ASCLEMED USA INC.	df8db06a-ced7-4dd6-83bd-c61d2f68f1b1	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	St. Mary's Medical Park Pharmacy	351ca54b-0eb6-4e93-8ab4-82fb18dcc9e1	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	QPharma, Inc.	f35bfd9e-afb6-409d-a804-6073d812609d	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	43785b49-5d1e-4ae9-b2ff-26be910bde7f	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	REMEDYREPACK INC.	a26772e7-6e4d-489b-bb5e-5bc322ef6dfe	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	df929b3f-0cda-4a75-96d3-22e6b0edbbc9	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	REMEDYREPACK INC.	bdc0c228-797a-42dd-8114-aa68c1eb3300	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	Coupler LLC	50380ce5-c77f-3ee3-e063-6394a90a17ae	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Citalopram generic name: CITALOPRAM
Citalopram	CITALOPRAM	Cardinal Health 107, LLC	6c8942f8-963a-4007-a147-b77ac629e4d4	2026-04-17	Boxed warning, Warnings, Adverse reactions	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