Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017090
Company: SPECGX LLC

• Medication Guide

• Other Important Information from FDA

Products on NDA 17090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOFRANIL-PM	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
TOFRANIL-PM	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
TOFRANIL-PM	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
TOFRANIL-PM	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 017090

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2014	SUPPL-78	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf
07/10/2014	SUPPL-77	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf
10/26/2012	SUPPL-76	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf
07/13/2007	SUPPL-74	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf
01/12/2005	SUPPL-70	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf