Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202220
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB 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
11/19/2012 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
07/17/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PROTRIPTYLINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202220 EPIC PHARMA LLC
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078913 HIKMA
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090462 SIGMAPHARM LABS LLC
VIVACTIL PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 073644 HERITAGE PHARMA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202220 EPIC PHARMA LLC
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078913 HIKMA
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090462 SIGMAPHARM LABS LLC
VIVACTIL PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 073645 HERITAGE PHARMA

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