Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065048
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFUROXIME | CEFUROXIME | 1.5G/20ML | Injectable; Injection | Prescription | None | No | No |
CEFUROXIME | CEFUROXIME | 1.5G/100ML | Injectable; Injection | Prescription | None | No | No |
CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | AB | No | Yes |
CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
01/09/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/07/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
07/07/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
11/16/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
04/12/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
01/16/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
CEFUROXIME
There are no Therapeutic Equivalents.
CEFUROXIME SODIUM
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 750MG BASE/VIAL
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AB | 064125 | ACS DOBFAR SPA |
CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AB | 065048 | HIKMA |
INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064125 | ACS DOBFAR SPA |
CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065048 | HIKMA |