Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014713
Company: SCHERING

• Other Important Information from FDA

Products on NDA 014713

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETRAFON 2-10	AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE	10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
ETRAFON 2-25	AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE	25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
ETRAFON-A	AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE	10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
ETRAFON-FORTE	AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE	25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 014713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/1969	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2002	SUPPL-32	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14713s031ltr.pdf
05/10/2002	SUPPL-31	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14713s031ltr.pdf
03/02/2001	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
08/18/2000	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/2000	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
09/10/1999	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
05/23/2000	SUPPL-26	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/21/1998	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/2000	SUPPL-24	Labeling		Label is not available on this site.
08/23/2000	SUPPL-23	Labeling		Label is not available on this site.
08/03/1988	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
12/07/1984	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/15/1984	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/17/1981	SUPPL-14	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/14/1980	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/29/1980	SUPPL-11	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/06/1979	SUPPL-10	Labeling		Label is not available on this site.