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 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
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
2026-02-19 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
2026-07-26 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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
citalopram	CITALOPRAM	Almatica Pharma LLC	2f815b0c-6da7-cb61-e89c-7de628092d0d	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215428 application number: NDA215428 ndc (product): 52427-691

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