Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208475
Company: B BRAUN MEDICAL INC
Company: B BRAUN MEDICAL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
09/08/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
INJECTABLE;INJECTION; 0.005MG/ML;1.5%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | No | AP | 208475 | B BRAUN MEDICAL INC |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | No | AP | 088571 | HOSPIRA |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | No | AP | 089645 | HOSPIRA |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |