Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090580
Company: SAGENT PHARMS
Company: SAGENT PHARMS
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 | 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 |
---|---|---|---|---|---|---|---|
08/24/2012 | 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 |
---|---|---|---|---|---|
01/27/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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01/27/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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01/27/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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01/27/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
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 |