Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065240
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM 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 |
---|---|---|---|---|---|---|---|
07/25/2006 | 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 |
---|---|---|---|---|---|
06/21/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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05/14/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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05/14/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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03/01/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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03/01/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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07/31/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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10/31/2007 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
AMPICILLIN AND SULBACTAM
INJECTABLE;INJECTION; EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065403 | ACS DOBFAR |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090339 | EUGIA PHARMA SPECLTS |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065076 | HIKMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065188 | HQ SPECLT PHARMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065314 | ISTITUTO BIO ITA SPA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065240 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202197 | STERISCIENCE SPECLTS |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050608 | PFIZER |