Application 078216
- Type
- ANDA
- Sponsor
- TORRENT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 003 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078216-001 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | |
| A078216-002 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | |
| A078216-003 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078216-001 | AB |
| A078216-002 | AB |
| A078216-003 | 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 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078216-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078216-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078216-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A078216-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078216-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078216-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078216-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078216-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078216-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078216-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078216-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078216-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078216-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078216-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078216-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078216-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078216-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078216-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078216-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078216-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078216-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078216-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078216-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078216-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078216-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078216-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078216-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078216-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078216-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078216-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078216-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078216-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078216-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078216-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078216-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078216-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078216-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078216-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078216-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078216-001 | AB | 1 | 79d66fd596c7… |
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 | Northwind Health Company, LLC | c133fc77-6c8a-d2b1-e053-2995a90ab5f7 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Advanced Rx of Tennessee, LLC | 434094b4-fa3b-385a-e063-6394a90ac638 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | c577b306-ee7c-8364-e053-2a95a90abb13 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | c584909b-e7b2-7108-e053-2995a90a2f54 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 68071-1830 |
| Citalopram | CITALOPRAM | Advanced Rx of Tennessee, LLC | b3541f26-dc8d-6591-e053-2995a90a23d9 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Quality Care Products, LLC | 6fc110ba-87e7-404e-9e00-b680f354c7b0 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 55700-851 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Quality Care Products, LLC | e22fe468-5d9e-4ec7-a69b-4988e0b8acbd | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 55700-787 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Bryant Ranch Prepack | 8719bd44-36b6-468d-9203-8c53a2645184 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Proficient Rx LP | 1a136cc3-d655-4f3c-8710-2603dc008492 | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 63187-203 63187-220 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Bryant Ranch Prepack | 15cb00da-4435-4930-90d0-faadf2739a5c | 2024-10-30 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | A-S Medication Solutions | 05421bee-f746-418e-bb9c-ab44a89b567d | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals, Inc. | 4f45c818-b324-6ca6-e054-00144ff8d46c | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 68071-2198 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | 579836d8-64ed-de2d-e053-2a91aa0a8392 | 2024-07-11 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 68071-1906 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | 549a5b3f-4928-1ae5-e054-00144ff8d46c | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | NuCare Pharmaceuticals,Inc. | 9987a273-e6d7-54cd-e053-2a95a90a0aaa | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | A-S Medication Solutions | 9059c8f1-8755-492d-aba2-5f5088ce69d3 | 2023-12-26 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | A-S Medication Solutions | 9d2f8f9f-9710-48e0-bc18-105a2af1073b | 2023-12-04 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Proficient Rx LP | 4eb71151-241a-476e-a495-4a021bc55bda | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
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 |
|---|---|---|---|---|---|
| 51655-664 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-667 | Citalopram Hydrobromide | Citalopram Hydrobromide | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53002-1579 | Citalopram Hydrobromide | Citalopram Hydrobromide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1579 | Citalopram Hydrobromide | Citalopram Hydrobromide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2359 | Citalopram Hydrobromide | Citalopram Hydrobromide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2359 | Citalopram Hydrobromide | Citalopram Hydrobromide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2360 | Citalopram Hydrobromide | Citalopram Hydrobromide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0225 | Citalopram Hydrobromide | Citalopram Hydrobromide | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0350 | Citalopram Hydrobromide | Citalopram Hydrobromide | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-3329 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-3329 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-3329 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-3329 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health 107, LLC | ANDA | Current |
| 55154-3329 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-3349 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-3349 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-3349 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-3349 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health 107, LLC | ANDA | Current |
| 55154-3349 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-5895 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55154-5895 | Citalopram Hydrobromide | Citalopram Hydrobromide | Cardinal Health | ANDA | Current |
| 55700-787 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-787 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-787 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-787 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-787 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-838 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-838 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-838 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-851 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-851 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-851 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-851 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 55700-851 | Citalopram Hydrobromide | Citalopram Hydrobromide | Quality Care Products, LLC | ANDA | Current |
| 58118-0023 | Citalopram Hydrobromide | Citalopram Hydrobromide | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0023 | Citalopram Hydrobromide | Citalopram Hydrobromide | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0023 | Citalopram Hydrobromide | Citalopram Hydrobromide | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-495 | Citalopram Hydrobromide | Citalopram Hydrobromide | St Marys Medical Park Pharmacy | ANDA | Current |
| 61919-259 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | Direct Rx | ANDA | Current |
| 61919-389 | Citalopram | Citalopram | Direct Rx | ANDA | Current |
| 61919-389 | Citalopram | Citalopram | Direct_Rx | ANDA | Current |
| 61919-389 | Citalopram | Citalopram | Direct_Rx | ANDA | Current |
| 61919-389 | Citalopram | Citalopram | Direct Rx | ANDA | Current |
| 61919-389 | Citalopram | Citalopram | Direct_Rx | ANDA | Current |
| 61919-389 | Citalopram | Citalopram | Direct Rx | ANDA | Current |
| 61919-390 | Citalopram | Citalopram | Direct Rx | ANDA | Current |
| 61919-390 | Citalopram | Citalopram | Direct Rx | ANDA | Current |
| 61919-390 | Citalopram | Citalopram | Direct Rx | ANDA | Current |
| 63187-203 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63187-203 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63187-203 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63187-203 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63187-220 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63187-220 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63187-220 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63187-220 | Citalopram Hydrobromide | Citalopram Hydrobromide | Proficient Rx LP | ANDA | Current |
| 63629-6789 | Citalopram Hydrobromide | Citalopram Hydrobromide | Bryant Ranch Prepack | ANDA | Current |
| 63629-6789 | Citalopram Hydrobromide | Citalopram Hydrobromide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8167 | Citalopram Hydrobromide | Citalopram Hydrobromide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8167 | Citalopram Hydrobromide | Citalopram Hydrobromide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8225 | Citalopram Hydrobromide | Citalopram Hydrobromide | Bryant Ranch Prepack | ANDA | Current |
| 64725-0010 | Citalopram Hydrobromide | Citalopram Hydrobromide | TYA Pharmaceuticals | ANDA | Current |
| 66116-405 | Citalopram Hydrobromide | Citalopram Hydrobromide | MedVantx, Inc. | ANDA | Current |
| 66116-409 | Citalopram Hydrobromide | Citalopram Hydrobromide | MedVantx, Inc. | ANDA | Current |
| 67046-110 | Citalopram Hydrobromide | Citalopram Hydrobromide | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-113 | Citalopram Hydrobromide | Citalopram Hydrobromide | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-114 | Citalopram Hydrobromide | Citalopram Hydrobromide | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1186 | Citalopram Hydrobromide | Citalopram Hydrobromide | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1186 | Citalopram Hydrobromide | Citalopram Hydrobromide | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1186 | Citalopram Hydrobromide | Citalopram Hydrobromide | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1830 | Citalopram Hydrobromide | Citalopram Hydrobromide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1906 | Citalopram Hydrobromide | Citalopram Hydrobromide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1906 | Citalopram Hydrobromide | Citalopram Hydrobromide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1906 | Citalopram Hydrobromide | Citalopram Hydrobromide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2198 | Citalopram Hydrobromide | Citalopram Hydrobromide | NuCare Pharmaceuticals, I | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23899 | ORIG | 2007-04-10 |