Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 012342
Company: ADVANZ PHARMA

Medication Guide

Other Important Information from FDA

Products on NDA 012342

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012342

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.

Labels for NDA 012342

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	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

Therapeutic Equivalents for NDA 012342

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	ADVANZ PHARMA
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 INTL