Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011213
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRILAFON PERPHENAZINE 5MG/ML INJECTABLE;INJECTION Discontinued None No 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
01/29/1958 ORIG-1 Approval Type 3 - New Dosage Form 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-24 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/2002/011213_S024_TRILAFON_AP.pdf
05/31/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2001 SUPPL-22 Labeling

Label is not available on this site.

03/15/2001 SUPPL-21 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
09/10/1999 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1997 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-14 Labeling

Label is not available on this site.

12/07/2007 SUPPL-11 Labeling

Label is not available on this site.

12/07/2007 SUPPL-9 Labeling

Label is not available on this site.

03/29/1982 SUPPL-8 Labeling

Label is not available on this site.

12/07/2007 SUPPL-7 Labeling

Label is not available on this site.

12/07/2007 SUPPL-6 Labeling

Label is not available on this site.

12/07/2007 SUPPL-5 Labeling

Label is not available on this site.

12/07/2007 SUPPL-4 Labeling

Label is not available on this site.

12/07/2007 SUPPL-3 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-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf

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