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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014685
Company: RANBAXY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVENTYL NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;ORAL Discontinued None Yes No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
11/06/1964 ORIG-1 Approval Type 3 - New Dosage Form 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
07/30/2007 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014685s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014685s028ltr.pdf
01/12/2005 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14685s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14685s026ltr.pdf
08/23/2000 SUPPL-24 Labeling

Label is not available on this site.
05/29/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
04/24/1998 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
08/23/2000 SUPPL-21 Labeling

Label is not available on this site.
07/08/1996 SUPPL-20 Labeling

Label is not available on this site.
07/08/1996 SUPPL-19 Labeling

Label is not available on this site.
05/10/1993 SUPPL-18 Labeling

Label is not available on this site.
05/10/1993 SUPPL-17 Labeling

Label is not available on this site.
05/10/1993 SUPPL-16 Labeling

Label is not available on this site.
06/20/1990 SUPPL-15 Labeling

Label is not available on this site.
06/20/1990 SUPPL-14 Labeling

Label is not available on this site.
02/16/1989 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
01/09/1987 SUPPL-12 Labeling

Label is not available on this site.
06/20/1990 SUPPL-11 Labeling

Label is not available on this site.
10/25/1985 SUPPL-10 Labeling

Label is not available on this site.
10/05/1984 SUPPL-9 Labeling

Label is not available on this site.
05/24/1984 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/27/1984 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/30/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014685s028lbl.pdf
01/12/2005 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14685s026lbl.pdf
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