Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077031
Company: AUROBINDO
Company: AUROBINDO
| 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77031ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2024 | SUPPL-44 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2023 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2022 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2022 | SUPPL-37 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/31/2022 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2022 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2012 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2012 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/06/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/14/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/02/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/25/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/25/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/28/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/09/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/07/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/06/2006 | SUPPL-1 | Labeling |
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 | 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 | 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 | 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 |