Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075606
Company: PHARM ASSOC
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
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
04/26/2010 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.

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 077965 TARO

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