Drugs@FDA: FDA Approved Drug Products

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

Label is not available on this site.

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.

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

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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