Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012342
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARNATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/21/1961 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2018 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012342s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012342s064ltr.pdf
05/14/2010 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012342s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012342s063ltr.pdf
11/27/2009 SUPPL-61 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012342s061lbl.pdf
08/02/2007 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012342s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf
01/23/2006 SUPPL-57 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012342s056s057ltr.pdf
01/23/2006 SUPPL-56 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012342s056s057ltr.pdf
01/12/2005 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12342s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12342s055ltr.pdf
10/23/2001 SUPPL-53 Labeling

Label is not available on this site.

07/14/1997 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/15/2001 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
03/15/2001 SUPPL-48 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
03/15/2001 SUPPL-46 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
03/15/2001 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
03/15/2001 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
03/15/2001 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
03/15/2001 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12342S51LTR.PDF
02/24/1988 SUPPL-36 Labeling

Label is not available on this site.

03/22/1984 SUPPL-31 Efficacy

Label is not available on this site.

03/22/1984 SUPPL-28 Efficacy-New Indication

Label is not available on this site.

04/06/1981 SUPPL-26 Labeling

Label is not available on this site.

05/20/1980 SUPPL-22 Labeling

Label is not available on this site.

06/20/1978 SUPPL-17 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2018 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012342s064lbl.pdf
05/14/2010 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012342s063lbl.pdf
11/27/2009 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012342s061lbl.pdf
08/02/2007 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012342s059lbl.pdf
01/12/2005 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12342s055lbl.pdf

PARNATE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PARNATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 012342 CONCORDIA
TRANYLCYPROMINE SULFATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET;ORAL Prescription No AB 206856 CNTY LINE PHARMS
TRANYLCYPROMINE SULFATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET;ORAL Prescription No AB 040640 PAR PHARM

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