Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200181
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENELZINE SULFATE PHENELZINE SULFATE EQ 15MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/08/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/17/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

PHENELZINE SULFATE

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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