Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020822
Company: FOREST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CELEXA CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
CELEXA CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription AB Yes No
CELEXA CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription AB Yes Yes
CELEXA CITALOPRAM HYDROBROMIDE EQ 60MG BASE TABLET;ORAL Discontinued None 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
07/17/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20822lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20822ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020822a.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf
07/08/2014 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf
04/16/2014 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s045ltr.pdf
06/17/2013 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/03/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf
03/27/2012 SUPPL-42 Labeling-Medication Guide Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822s042,021046s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020822Orig1s042.pdf
08/12/2011 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf
08/12/2011 SUPPL-38 Labeling-Medication Guide Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf
01/30/2009 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf
09/18/2008 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,ltr.pdf
08/02/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020822s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf
02/18/2005 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020822s29lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf
05/20/2004 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf
04/08/2004 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21046slr005,20822slr023ltr.pdf
11/19/2002 SUPPL-19 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20822slr019,21046slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020822_s019_CelexaTOC.cfm
05/30/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/10/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/17/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/22/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/27/2001 SUPPL-11 Labeling

Label is not available on this site.

06/27/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/27/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/13/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1999 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1999 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/13/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/19/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf
07/08/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf
04/16/2014 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822s045lbl.pdf
12/03/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s043lbl.pdf
03/27/2012 SUPPL-42 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf
08/12/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf
08/12/2011 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf
01/30/2009 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf
09/18/2008 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf
08/02/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020822s034lbl.pdf
02/18/2005 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020822s29lbl.pdf
07/17/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20822lbl.pdf

CELEXA

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 FOREST LABS
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 INC
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 CIPLA LTD
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 077048 G AND W LABS INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077654 GLENMARK GENERICS
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 205407 JUBILANT GENERICS
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 077232 PLIVA
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077032 SUN PHARM INDS INC
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 FOREST LABS
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 INC
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 CIPLA LTD
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 077048 G AND W LABS INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077654 GLENMARK GENERICS
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 205407 JUBILANT GENERICS
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 077232 PLIVA
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077032 SUN PHARM INDS INC
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 FOREST LABS
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 INC
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 CIPLA LTD
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 077048 G AND W LABS INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077654 GLENMARK GENERICS
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 205407 JUBILANT GENERICS
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 077232 PLIVA
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077032 SUN PHARM INDS INC
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 078216 TORRENT PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English