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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078216-002 | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078216-003 | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078216-001 | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-27 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078216-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078216-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078216-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078216-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078216-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078216-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078216-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078216-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078216-001 | AB | 1 | 8072bd15b7f6… |
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 | PD-Rx Pharmaceuticals, Inc. | 9fe40d83-8945-4577-add5-28d52410154e | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | St. Mary's Medical Park Pharmacy | db900453-4777-4142-a236-5d3a6152d0a5 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Coupler LLC | 53e5d66f-7902-76ac-e063-6294a90aa526 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Coupler LLC | 53e6d0a4-95d9-9c1a-e063-6294a90a9d18 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Bryant Ranch Prepack | 9b53c14c-224c-49ed-8a00-96f871593ab0 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | ASCLEMED USA INC. | df8db06a-ced7-4dd6-83bd-c61d2f68f1b1 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | St. Mary's Medical Park Pharmacy | 351ca54b-0eb6-4e93-8ab4-82fb18dcc9e1 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | QPharma, Inc. | f35bfd9e-afb6-409d-a804-6073d812609d | 2026-05-08 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 42708-091 |
| Citalopram | CITALOPRAM | PD-Rx Pharmaceuticals, Inc. | 43785b49-5d1e-4ae9-b2ff-26be910bde7f | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 43063-683 |
| Citalopram | CITALOPRAM | REMEDYREPACK INC. | a26772e7-6e4d-489b-bb5e-5bc322ef6dfe | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | PD-Rx Pharmaceuticals, Inc. | df929b3f-0cda-4a75-96d3-22e6b0edbbc9 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 43063-481 |
| Citalopram | CITALOPRAM | REMEDYREPACK INC. | bdc0c228-797a-42dd-8114-aa68c1eb3300 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Coupler LLC | 50380ce5-c77f-3ee3-e063-6394a90a17ae | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Cardinal Health 107, LLC | 6c8942f8-963a-4007-a147-b77ac629e4d4 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Preferred Pharmaceuticals Inc. | 27ddea53-f03d-4760-99bb-ec8efa44ff62 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Bryant Ranch Prepack | bef27fa1-7876-4ce3-834c-a4855aec66c9 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Major Pharmaceuticals | a6949652-b15b-435b-9097-2219f398ac05 | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 0904-6084 0904-6085 |
| Citalopram | CITALOPRAM | Torrent Pharmaceuticals Limited | 04766f1d-7a69-49ed-8fd3-1a6305505d47 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 13668-009 13668-010 13668-011 |
| Citalopram Hydrobromide | CITALOPRAM HYDROBROMIDE | Preferred Pharmaceuticals, Inc. | b52acd68-fed1-4680-9eaf-b72e7dcba6fb | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 |
| Citalopram | CITALOPRAM | Northwind Health Company, LLC | a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078216 ANDA078216 51655-664 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-7830 | Citalopram Hydrobromide | Citalopram Hydrobromide | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7831 | Citalopram Hydrobromide | Citalopram Hydrobromide | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7832 | Citalopram Hydrobromide | Citalopram Hydrobromide | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6084 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6084 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6084 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6084 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6085 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6085 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6085 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6085 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6086 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 0904-6086 | Citalopram Hydrobromide | Citalopram Hydrobromide | Major Pharmaceuticals | ANDA | Current |
| 10544-543 | Citalopram Hydrobromide | Citalopram Hydrobromide | Blenheim Pharmacal, Inc. | ANDA | Current |
| 12634-023 | Citalopram Hydrobromide | Citalopram Hydrobromide | Apotheca Inc. | ANDA | Current |
| 12634-027 | Citalopram Hydrobromide | Citalopram Hydrobromide | Apotheca Inc. | ANDA | Current |
| 12634-629 | Citalopram Hydrobromide | Citalopram Hydrobromide | Apotheca Inc. | ANDA | Current |
| 13668-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-009 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-010 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-010 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-010 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-010 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-010 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-011 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-011 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-011 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-011 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-011 | Citalopram Hydrobromide | Citalopram Hydrobromide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 21695-030 | Citalopram | Citalopram Hydrobromide | Rebel Distributors Corp. | ANDA | Current |
| 21695-031 | Citalopram | Citalopram Hydrobromide | Rebel Distributors Corp. | ANDA | Current |
| 21695-032 | Citalopram | Citalopram Hydrobromide | Rebel Distributors Corp. | ANDA | Current |
| 33261-026 | Citalopram Hydrobromide | Citalopram Hydrobromide | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-027 | Citalopram Hydrobromide | Citalopram Hydrobromide | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-028 | Citalopram Hydrobromide | Citalopram Hydrobromide | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42254-108 | Citalopram Hydrobromide | Citalopram Hydrobromide | Rebel Distributors Corp | ANDA | Current |
| 42254-116 | Citalopram Hydrobromide | Citalopram Hydrobromide | Rebel Distributors Corp | ANDA | Current |
| 42254-119 | Citalopram Hydrobromide | Citalopram Hydrobromide | Rebel Distributors Corp | ANDA | Current |
| 42708-091 | Citalopram Hydrobromide | Citalopram Hydrobromide | QPharma Inc | ANDA | Current |
| 42708-091 | Citalopram Hydrobromide | Citalopram Hydrobromide | QPharma Inc | ANDA | Current |
| 42708-091 | Citalopram Hydrobromide | Citalopram Hydrobromide | QPharma Inc | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-481 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-683 | Citalopram Hydrobromide | Citalopram Hydrobromide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-0892 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-0892 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-0892 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-1298 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-1298 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-1298 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-1298 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-2774 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-2888 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-3208 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-3208 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-3208 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50090-3498 | Citalopram Hydrobromide | Citalopram Hydrobromide | A-S Medication Solutions | ANDA | Current |
| 50436-0916 | Citalopram Hydrobromide | Citalopram Hydrobromide | Unit Dose Services | ANDA | Current |
| 51655-043 | Citalopram Hydrobromide | Citalopram Hydrobromide | Northwind Pharmaceuticals | ANDA | Current |
| 51655-664 | Citalopram Hydrobromide | Citalopram Hydrobromide | Northwind Pharmaceuticals, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23899 | ORIG | 2007-04-10 |