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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018012
Company: SPECGX LLC

Medication Guide

Other Important Information from FDA

Products on NDA 018012

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018012

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.

Labels for NDA 018012

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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