Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006488
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 1.5% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;2% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;1% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.02MG/ML;2% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;0.5% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;2% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-97 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006488s097lbl.pdf | |
12/22/2017 | SUPPL-95 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf | |
12/22/2017 | SUPPL-90 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf | |
02/19/2010 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf |