Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061395
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1971 | 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 |
|---|---|---|---|---|---|
| 04/16/2020 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2018 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/01/2015 | SUPPL-37 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/25/2011 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2015 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/31/2007 | SUPPL-29 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/04/2004 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/04/2004 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
AMPICILLIN SODIUM
INJECTABLE;INJECTION; EQ 125MG 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 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090583 | SAGENT PHARMS INC |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 061395 | SANDOZ |
INJECTABLE;INJECTION; EQ 250MG 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 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090354 | ANTIBIOTICE |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065499 | AUROBINDO PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062772 | HQ SPECLT PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062719 | ISTITUTO BIO ITA SPA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201025 | MYLAN LABS LTD |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090583 | SAGENT PHARMS INC |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 061395 | SANDOZ |
INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090354 | ANTIBIOTICE |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065499 | AUROBINDO PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062772 | HQ SPECLT PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062719 | ISTITUTO BIO ITA SPA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201025 | MYLAN LABS LTD |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090583 | SAGENT PHARMS INC |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 061395 | SANDOZ |
INJECTABLE;INJECTION; EQ 1GM 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 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090354 | ANTIBIOTICE |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065499 | AUROBINDO PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062772 | HQ SPECLT PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062719 | ISTITUTO BIO ITA SPA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201025 | MYLAN LABS LTD |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090583 | SAGENT PHARMS INC |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 061395 | SANDOZ |
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 |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090354 | ANTIBIOTICE |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065499 | AUROBINDO PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062772 | HQ SPECLT PHARMA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062797 | ISTITUTO BIO ITA SPA |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201025 | MYLAN LABS LTD |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090583 | SAGENT PHARMS INC |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 061395 | SANDOZ |
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 |