Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061667
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/6ML | FOR SOLUTION;ORAL | Discontinued | None | No | No |
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
07/13/1983 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/061667Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/29/2021 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
01/29/2021 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
06/20/2019 | SUPPL-26 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/061667Orig1s026.pdf | |
09/09/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
06/20/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/29/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
07/12/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
05/17/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
VANCOCIN HYDROCHLORIDE
FOR SOLUTION;ORAL; EQ 250MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 061667 | ANI PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 215338 | AMNEAL |