Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 010775
Company: SCHERING
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TRILAFON PERPHENAZINE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TRILAFON PERPHENAZINE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TRILAFON PERPHENAZINE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TRILAFON PERPHENAZINE 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English