Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020971
Company: DEPROCO
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 |
| 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 |