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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011213
Company: SCHERING

Products on NDA 011213

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRILAFON	PERPHENAZINE	5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011213

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.

Labels for NDA 011213

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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