Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062719
Company: ISTITUTO BIO ITA SPA
Company: ISTITUTO BIO ITA SPA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG 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 |
|---|---|---|---|---|---|---|---|
| 05/12/1987 | 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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2024 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/15/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/15/2018 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/15/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
AMPICILLIN SODIUM
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 | EUGIA PHARMA SPECLTS |
| 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 | 090583 | SAGENT PHARMS INC |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG 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 | EUGIA PHARMA SPECLTS |
| 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 | ONESOURCE SPECIALTY |
| 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 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 | EUGIA PHARMA SPECLTS |
| 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 | 090583 | SAGENT PHARMS INC |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 061395 | SANDOZ |