Drugs@FDA: FDA-Approved Drugs
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 | 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 |
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 |