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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011909
Company: PARKE DAVIS

Medication Guide

Other Important Information from FDA

Products on NDA 011909

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NARDIL	PHENELZINE SULFATE	EQ 15MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011909

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/1961	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2007	SUPPL-38	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf
02/06/2007	SUPPL-36	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011909s036ltr.pdf
02/18/2005	SUPPL-35	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11909s035ltr.pdf
09/02/2003	SUPPL-33	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/11909slr033_nardil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11909slr033ltr.pdf
01/03/2002	SUPPL-30	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/011909Orig1s030.pdf
02/25/1998	SUPPL-28	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/24/1998	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
07/14/1994	SUPPL-23	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/28/1985	SUPPL-13	Labeling		Label is not available on this site.
11/03/1982	SUPPL-12	Labeling		Label is not available on this site.
08/27/1986	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/1978	SUPPL-9	Labeling		Label is not available on this site.
08/27/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 011909

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2007	SUPPL-38	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s038lbl.pdf
02/06/2007	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf
02/06/2007	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf
09/02/2003	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/11909slr033_nardil_lbl.pdf

Therapeutic Equivalents for NDA 011909

NARDIL

TABLET;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NARDIL	PHENELZINE SULFATE	EQ 15MG BASE	TABLET;ORAL	Prescription	Yes	AB	011909	PARKE DAVIS
PHENELZINE SULFATE	PHENELZINE SULFATE	EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	200181	NOVEL LABS INC

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