Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090889
Company: ACS DOBFAR SPA
Company: ACS DOBFAR SPA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPICILLIN SODIUM | AMPICILLIN 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 |
---|---|---|---|---|---|---|---|
04/03/2013 | 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 |
---|---|---|---|---|---|
04/03/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
AMPICILLIN 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 |
---|---|---|---|---|---|---|---|---|
AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090889 | ACS DOBFAR SPA |
AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065493 | AUROBINDO PHARMA |
AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 063142 | HQ SPECLT PHARMA |
AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201404 | ISTITUTO BIO ITA SPA |
AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202198 | MYLAN LABS LTD |
AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090581 | SAGENT PHARMS INC |
AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 061395 | SANDOZ |
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