Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021496
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DUOCAINE | BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE | EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/23/2003 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21496_duocaine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21496ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21496_Duocaine.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/23/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21496_duocaine_lbl.pdf |