Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 062732
Company: SANDOZ
Company: SANDOZ
| 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 | Yes |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM 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 |
|---|---|---|---|---|---|---|---|
| 12/23/1986 | 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 |
|---|---|---|---|---|---|
| 01/03/2016 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/29/2013 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2016 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/13/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/26/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1990 | SUPPL-1 | Manufacturing (CMC) |
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 | AUROBINDO PHARMA LTD |
| 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 | 062527 | SANDOZ |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062732 | SANDOZ |
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 | AUROBINDO PHARMA LTD |
| 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 | 062527 | SANDOZ |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062732 | SANDOZ |
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