Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040640
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANYLCYPROMINE SULFATE TRANYLCYPROMINE SULFATE EQ 10MG 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
06/29/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040640s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/12/2007 SUPPL-7 Labeling

Label is not available on this site.

12/12/2007 SUPPL-5 Labeling

Label is not available on this site.

TRANYLCYPROMINE SULFATE

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 206856 CNTY LINE PHARMS
TRANYLCYPROMINE SULFATE TRANYLCYPROMINE SULFATE EQ 10MG BASE TABLET;ORAL Prescription No AB 040640 PAR PHARM

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