Drugs@FDA: FDA-Approved Drugs
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 | 213503 | CROSSMEDIKA SA |
TRANYLCYPROMINE SULFATE | TRANYLCYPROMINE SULFATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206856 | NOVITIUM PHARMA |
TRANYLCYPROMINE SULFATE | TRANYLCYPROMINE SULFATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 040640 | STRIDES PHARMA |