Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020971
Company: DEPROCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEPTOCAINE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/03/2000 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020971_SeptocaineTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020971s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020971Orig1s042ltr.pdf
01/12/2017 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/27/2016 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/26/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/05/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/05/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/14/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/08/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/12/2010 SUPPL-23 Labeling-Container/Carton Labels Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2010/020971Orig1s023.pdf
02/22/2010 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020971s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020971Orig1s021.pdf
11/09/2006 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020971s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020971s017LTR.pdf
03/30/2006 SUPPL-15 Labeling

Label is not available on this site.

03/30/2006 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020971Orig1s013.pdf
02/04/2005 SUPPL-9 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20971s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020971Orig1s009.pdf
10/14/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20971s007ltr.pdf
07/23/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020971s042lbl.pdf
02/22/2010 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020971s021lbl.pdf
11/09/2006 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020971s017lbl.pdf
04/03/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_prntlbl.pdf

SEPTOCAINE

INJECTABLE;INJECTION; 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 079138 HOSPIRA
SEPTOCAINE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 020971 DEPROCO

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