Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073644
Company: CHARTWELL RX

• Other Important Information from FDA

Products on ANDA 073644

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIVACTIL	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073644

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.

Labels for ANDA 073644

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