Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018012
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE/5ML SOLUTION;ORAL Discontinued None 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
08/01/1977 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
07/28/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf
07/10/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf
10/26/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf
07/13/2007 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018012s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf
01/12/2005 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf
07/31/2001 SUPPL-24 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018012s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018012_s024_PAMELOR CAPSULES.pdf
12/23/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1994 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/13/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1985 SUPPL-10 Labeling

Label is not available on this site.

05/01/1984 SUPPL-8 Labeling

Label is not available on this site.

07/07/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/25/1981 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/1980 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/15/1979 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/29/1978 SUPPL-1 Efficacy

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s031lbl.pdf
07/10/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf
10/26/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf
07/13/2007 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018012s27lbl.pdf
01/12/2005 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf
07/31/2001 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018012s24lbl.pdf

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