Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075606
Company: PHARM ASSOC

Products on ANDA 075606

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075606

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75606ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/26/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/07/2009	SUPPL-5	Labeling		Label is not available on this site.
10/06/2005	SUPPL-2	Labeling		Label is not available on this site.
08/22/2001	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075606

NORTRIPTYLINE HYDROCHLORIDE

SOLUTION;ORAL; EQ 10MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	075606	PHARM ASSOC
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	217731	RUBICON