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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050685
Company: BURKE THERAP

Products on NDA 050685

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEDAX	CEFTIBUTEN DIHYDRATE	EQ 400MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050685

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/1995	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050685Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2010	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf
02/10/2009	SUPPL-11	Labeling	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf
05/19/2000	SUPPL-8	Labeling		Label is not available on this site.
07/23/1999	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/16/1999	SUPPL-6	Labeling		Label is not available on this site.
09/03/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/26/1996	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/21/1997	SUPPL-3	Labeling		Label is not available on this site.
10/09/1996	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050685

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2009	SUPPL-11	Labeling	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf

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