Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050608
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050608Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050608s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050608Orig1s053ltr.pdf | |
| 10/09/2020 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050608s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050608Orig1s047ltr.pdf | |
| 04/19/2018 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050608s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050608Orig1s046ltr.pdf | |
| 02/13/2017 | SUPPL-44 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050608s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050608Orig1s044ltr.pdf |
| 02/09/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050608Orig1s041,s042ltr.pdf | |
| 11/17/2014 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050608Orig1s041,s042ltr.pdf | |
| 03/06/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050608s040ltr.pdf | |
| 12/14/2012 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2008 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050608s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050608s029ltr.pdf | |
| 08/19/2004 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50608s026ltr.pdf |
| 03/13/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1996 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1997 | SUPPL-19 | Efficacy-New Patient Population |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050608ap.pdf |
| 12/10/1993 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/08/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/24/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1992 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1992 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/02/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/22/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050608s053lbl.pdf | |
| 10/09/2020 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050608s047lbl.pdf | |
| 04/19/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050608s046lbl.pdf | |
| 02/13/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050608s044lbl.pdf |
| 02/13/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050608s044lbl.pdf |
| 11/17/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf | |
| 11/17/2014 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050608s041s042lbl.pdf | |
| 03/06/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf | |
| 04/14/2008 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050608s029lbl.pdf |
UNASYN
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 |
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 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 |
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050608 | PFIZER |