Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091486
Company: STERISCIENCE SPECLTS
Company: STERISCIENCE SPECLTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
OXACILLIN SODIUM | OXACILLIN 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 |
---|---|---|---|---|---|---|---|
08/25/2014 | 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 |
---|---|---|---|---|---|
02/04/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
OXACILLIN SODIUM
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 |
---|---|---|---|---|---|---|---|---|
OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201539 | EUGIA PHARMA SPECLTS |
OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206198 | FRESENIUS KABI USA |
OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091246 | SAGENT PHARMS |
OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091486 | STERISCIENCE SPECLTS |
OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207147 | WOCKHARDT BIO AG |