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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020971
Company: DEPROCO

Products on NDA 020971

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	None	Yes	Yes
SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020971

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.

Labels for NDA 020971

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

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