Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065074
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM 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 |
---|---|---|---|---|---|---|---|
03/19/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65074ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/15/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
01/02/2004 | SUPPL-10 | Labeling |
Label is not available on this site. |
AMPICILLIN AND SULBACTAM
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL;EQ 500MG 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 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065406 | ACS DOBFAR |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201406 | ANTIBIOTICE |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090349 | EUGIA PHARMA SPECLTS |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065074 | HIKMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065176 | HQ SPECLT PHARMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065222 | ISTITUTO BIO ITA SPA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065241 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065310 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201024 | STERISCIENCE |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050608 | PFIZER |
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL;EQ 1GM 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 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065406 | ACS DOBFAR |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201406 | ANTIBIOTICE |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090349 | EUGIA PHARMA SPECLTS |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065074 | HIKMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065176 | HQ SPECLT PHARMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065222 | ISTITUTO BIO ITA SPA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065241 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065310 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201024 | STERISCIENCE |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050608 | PFIZER |