Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065047
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM 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 |
---|---|---|---|---|---|---|---|
09/18/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/065047.pdf |
CEFAZOLIN SODIUM
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065303 | ACS DOBFAR |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065047 | HIKMA FARMACEUTICA |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062831 | SANDOZ |
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065303 | ACS DOBFAR |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065047 | HIKMA FARMACEUTICA |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203661 | QILU |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062831 | SANDOZ |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065345 | SANDOZ |