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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040218
Company: PH HEALTH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET;ORAL Discontinued None No No
AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET;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
09/11/1997 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2025 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
04/25/2016 SUPPL-23 Labeling-Package Insert

Label is not available on this site.
07/17/2014 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
04/26/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
11/21/2007 SUPPL-14 Labeling

Label is not available on this site.
06/29/2007 SUPPL-12 Labeling

Label is not available on this site.
10/06/2005 SUPPL-9 Labeling

Label is not available on this site.
08/03/2005 SUPPL-8 Labeling

Label is not available on this site.
03/26/2002 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
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