Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073644
Company: ODYSSEY PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIVACTIL PROTRIPTYLINE HYDROCHLORIDE 5MG 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
08/24/1995 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-23 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/073645s028,073644s023lbl.pdf
06/25/2007 SUPPL-17 Labeling

Label is not available on this site.

04/05/2006 SUPPL-10 Labeling

Label is not available on this site.

07/18/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

08/03/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2000 SUPPL-3 Labeling

Label is not available on this site.

07/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/073645s028,073644s023lbl.pdf

VIVACTIL

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 090462 SIGMAPHARM LABS LLC
PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078913 WEST-WARD PHARMS INT
VIVACTIL PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 073644 ODYSSEY PHARMS

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