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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010775
Company: SCHERING

Products on NDA 010775

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRILAFON	PERPHENAZINE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TRILAFON	PERPHENAZINE	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TRILAFON	PERPHENAZINE	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TRILAFON	PERPHENAZINE	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010775

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/1957	ORIG-1	Approval	Type 1 - New Molecular Entity	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-31	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10775s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/010775_S031_TRILAFON_AP.pdf
10/18/2001	SUPPL-30	Labeling		Label is not available on this site.
03/15/2001	SUPPL-29	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10775S29ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/10-775SLR029.pdf
03/03/2000	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/1999	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
06/01/2000	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.
10/20/1995	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
03/29/1982	SUPPL-15	Labeling		Label is not available on this site.

Labels for NDA 010775

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2002	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf

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