Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073009
Company: CHARTWELL RX

Products on ANDA 073009

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE	10MG;4MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073009

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/1991	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
02/23/2017	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
04/25/2016	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
01/16/2015	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/17/2014	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
11/03/2015	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
04/25/2001	SUPPL-22	Labeling		Label is not available on this site.
02/28/2001	SUPPL-21	Labeling		Label is not available on this site.
04/12/2001	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
03/21/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
05/07/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/16/1998	SUPPL-16	Labeling		Label is not available on this site.
06/16/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/16/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/08/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/31/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/31/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/29/1996	SUPPL-7	Labeling		Label is not available on this site.
03/26/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/26/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/26/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/26/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/29/1995	SUPPL-2	Labeling		Label is not available on this site.
08/31/1993	SUPPL-1	Labeling		Label is not available on this site.