Application 077141
- Type
- ANDA
- Sponsor
- NATCO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
| 002 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077141-001 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | ||
| A077141-002 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077141-001 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | 2008-04-10 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077141-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | 2008-04-10 | bb7c543d1eb4… |
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 Hydrobromide | CITALOPRAM HYDROBROMIDE | Preferred Pharmaceuticals Inc. | 27ddea53-f03d-4760-99bb-ec8efa44ff62 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | REMEDYREPACK INC. | 625a78b2-4751-4ca5-91b6-7c85fd9f8c2e | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM | Aphena Pharma Solutions - Tennessee, LLC | 7307df53-d570-4e26-971d-e97522ccce7f | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Preferred Pharmaceuticals, Inc. | b52acd68-fed1-4680-9eaf-b72e7dcba6fb | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | Northwind Health Company, LLC | d9cc1649-913d-832d-e053-2995a90a5f9a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | Northwind Health Company, LLC | d9ccb3fb-b607-9491-e053-2995a90a39c9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Northwind Health Company, LLC | c133fc77-6c8a-d2b1-e053-2995a90ab5f7 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | QPharma, Inc. | 0a967468-3869-4c8c-849f-9fc3a8dcc489 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | 31a18cdf-b0aa-18f5-e054-00144ff8d46c | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | 544ba802-a536-579a-e054-00144ff88e88 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | Bryant Ranch Prepack | 0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52 | 2025-06-11 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | ATLANTIC BIOLOGICALS CORP. | 2640311d-8b88-4513-9c80-a08390b8142a | 2025-05-12 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram | CITALOPRAM HYDROBROMIDE | REMEDYREPACK INC. | 0109f365-bebd-4810-a56f-4451e10245db | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | c577b306-ee7c-8364-e053-2a95a90abb13 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | c584909b-e7b2-7108-e053-2995a90a2f54 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide 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 | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Quality Care Products, LLC | 6fc110ba-87e7-404e-9e00-b680f354c7b0 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Quality Care Products, LLC | e22fe468-5d9e-4ec7-a69b-4988e0b8acbd | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Bryant Ranch Prepack | 8719bd44-36b6-468d-9203-8c53a2645184 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Proficient Rx LP | 1a136cc3-d655-4f3c-8710-2603dc008492 | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE |