Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077289
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/30/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/2024 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2024 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2024 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 01/08/2024 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2024 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/03/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/20/2008 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
CITALOPRAM HYDROBROMIDE
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELEXA | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020822 | ABBVIE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077289 | AMNEAL PHARMS NY |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077046 | APOTEX |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077031 | AUROBINDO |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077044 | CHARTWELL MOLECULAR |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077048 | COSETTE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077038 | DR REDDYS LABS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077045 | EPIC PHARMA |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077654 | GLENMARK PHARMS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077534 | INVAGEN PHARMS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077042 | MYLAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078216 | TORRENT PHARMS |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELEXA | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020822 | ABBVIE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077289 | AMNEAL PHARMS NY |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077046 | APOTEX |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077031 | AUROBINDO |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077044 | CHARTWELL MOLECULAR |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077048 | COSETTE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077038 | DR REDDYS LABS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077045 | EPIC PHARMA |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077654 | GLENMARK PHARMS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077534 | INVAGEN PHARMS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077042 | MYLAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078216 | TORRENT PHARMS |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELEXA | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020822 | ABBVIE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077289 | AMNEAL PHARMS NY |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077046 | APOTEX |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077031 | AUROBINDO |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077044 | CHARTWELL MOLECULAR |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077048 | COSETTE |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077038 | DR REDDYS LABS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077045 | EPIC PHARMA |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077654 | GLENMARK PHARMS LTD |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077534 | INVAGEN PHARMS |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077042 | MYLAN |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 078216 | TORRENT PHARMS |