Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090002
Company: ISTITUTO BIO ITA SPA
Company: ISTITUTO BIO ITA SPA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM 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 |
---|---|---|---|---|---|---|---|
06/30/2011 | 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 |
---|---|---|---|---|---|
03/08/2018 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
NAFCILLIN SODIUM
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 |
---|---|---|---|---|---|---|---|---|
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090560 | ANTIBIOTICE |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091613 | EUGIA PHARMA SPECLTS |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090002 | ISTITUTO BIO ITA SPA |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090582 | SAGENT PHARMS |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200002 | STERISCIENCE SPECLTS |
INJECTABLE;INJECTION; EQ 2GM 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 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090560 | ANTIBIOTICE |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091613 | EUGIA PHARMA SPECLTS |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090002 | ISTITUTO BIO ITA SPA |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090582 | SAGENT PHARMS |
NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200002 | STERISCIENCE SPECLTS |