Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062663
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG 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 |
|---|---|---|---|---|---|---|---|
| 03/17/1987 | 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 |
|---|---|---|---|---|---|
| 05/24/2021 | SUPPL-94 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2020 | SUPPL-90 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2020 | SUPPL-86 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/12/2017 | SUPPL-85 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/12/2017 | SUPPL-83 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/2002 | SUPPL-36 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/2001 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/13/2000 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/2000 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-28 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/13/2000 | SUPPL-27 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/13/2000 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/01/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1997 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/28/1997 | SUPPL-19 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 07/05/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/03/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/04/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/07/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
VANCOMYCIN HYDROCHLORIDE
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 |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216591 | ASPIRO |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205780 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204107 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062911 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062931 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215197 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065397 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212332 | SLATE RUN PHARMA |
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 |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216591 | ASPIRO |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205780 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203300 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204107 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062912 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062933 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215197 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065397 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212332 | SLATE RUN PHARMA |
INJECTABLE;INJECTION; EQ 5GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205779 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204360 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 063076 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215196 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065432 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200837 | SAGENT PHARMS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215821 | SLATE RUN PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204125 | XELLIA PHARMS APS |
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 |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205779 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204360 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 063076 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065455 | HOSPIRA INC |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215196 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091554 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200837 | SAGENT PHARMS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215821 | SLATE RUN PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204125 | XELLIA PHARMS APS |
INJECTABLE;INJECTION; EQ 750MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206616 | HIKMA PHARMS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062912 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062933 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215195 | MEITHEAL |