Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091614
Company: EUGIA PHARMA SPECLTS
Company: EUGIA PHARMA SPECLTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 10GM 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 |
---|---|---|---|---|---|---|---|
12/26/2012 | ORIG-1 | Approval |
Label is not available on this site. |
NAFCILLIN SODIUM
INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091614 | EUGIA PHARMA SPECLTS |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206761 | FRESENIUS |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090005 | ISTITUTO BIO ITA SPA |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090580 | SAGENT PHARMS |