Application 215428
- Type
- NDA
- Sponsor
- ALMATICA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CITALOPRAM | CITALOPRAM | CAPSULE; ORAL | 30MG | No | No |
Orange Book products#
| 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#
| 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 | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CITALOPRAM | CITALOPRAM | Aurobindo Pharma Limited | 80af8ae8-c106-4895-bab3-0579b41f1e75 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM CITALOPRAM |
| Citalopram | CITALOPRAM | Bryant Ranch Prepack | bef27fa1-7876-4ce3-834c-a4855aec66c9 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM | Aphena Pharma Solutions - Tennessee, LLC | 7307df53-d570-4e26-971d-e97522ccce7f | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM |
| Citalopram | CITALOPRAM | Major Pharmaceuticals | a6949652-b15b-435b-9097-2219f398ac05 | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM | Chartwell RX, LLC | b1f0c6e8-85eb-4368-8709-9cace32415cb | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM | Torrent Pharmaceuticals Limited | 04766f1d-7a69-49ed-8fd3-1a6305505d47 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM | Northwind Health Company, LLC | f2b42bdc-47e0-19c5-e053-2a95a90a1828 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM | Chartwell Governmental & Specialty RX, LLC. | 3114274f-d81f-4b1f-8f17-35db9eee2ffe | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM | Northwind Health Company, LLC | f2b54f10-221f-5eed-e053-2995a90ab47f | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM HYDROBROMIDE | Northwind Health Company, LLC | d9cc1649-913d-832d-e053-2995a90a5f9a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Citalopram |
| Citalopram | CITALOPRAM HYDROBROMIDE | Northwind Health Company, LLC | d9ccb3fb-b607-9491-e053-2995a90a39c9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Citalopram |
| Citalopram | CITALOPRAM | Northwind Health Company, LLC | f77ef23b-3015-d074-e053-6394a90a11e1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM HYDROBROMIDE | QPharma, Inc. | 0a967468-3869-4c8c-849f-9fc3a8dcc489 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | Citalopram |
| Citalopram | CITALOPRAM | Advanced Rx of Tennessee, LLC | 434094b4-fa3b-385a-e063-6394a90ac638 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | 31a18cdf-b0aa-18f5-e054-00144ff8d46c | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | Citalopram |
| Citalopram | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | 544ba802-a536-579a-e054-00144ff88e88 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | Citalopram |
| Citalopram | CITALOPRAM HYDROBROMIDE | Bryant Ranch Prepack | 0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52 | 2025-06-11 | Boxed warning, Warnings, Adverse reactions | Citalopram |
| CITALOPRAM | CITALOPRAM | Golden State Medical Supply, Inc. | f3a26d92-b662-4896-82eb-261948042408 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM CITALOPRAM |
| Citalopram | CITALOPRAM | PD-Rx Pharmaceuticals, Inc. | 75f6db65-e4ed-470a-9e56-12791f22ee9b | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
| Citalopram | CITALOPRAM | Advanced Rx of Tennessee, LLC | b3541f26-dc8d-6591-e053-2995a90a23d9 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Citalopram CITALOPRAM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52427-691 | citalopram | citalopram | Almatica Pharma LLC | NDA | Current |