Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/17/2004 | ORIG-19 | Approval | Supplement | STANDARD |
Label is not available on this site. |
||
04/15/1986 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2021 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050606s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050606Orig1s039ltr.pdf | |
01/29/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050606s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050606Orig1s038ltr.pdf | |
08/11/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050606Orig1s0036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050606Orig1s036ltr.pdf | |
12/14/2011 | SUPPL-28 | Efficacy-Accelerated Approval Confirmatory Study |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050606s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050606s028ltr.pdf | |
01/08/2010 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050606s026ltr.pdf |
05/27/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50606slr020_vancocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50606slr020ltr.pdf | |
03/17/2004 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50606slr019ltr.pdf |
05/28/2002 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/24/2002 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50606s015ltr.pdf |
02/06/2001 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
03/18/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/12/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
06/30/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
06/14/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
09/27/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/14/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
05/23/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
08/18/1987 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/12/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
10/08/1986 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
06/05/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/22/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050606s039lbl.pdf | |
01/29/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050606s038lbl.pdf | |
08/11/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050606Orig1s0036lbl.pdf | |
12/14/2011 | SUPPL-28 | Efficacy-Accelerated Approval Confirmatory Study | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050606s028lbl.pdf | |
05/27/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50606slr020_vancocin_lbl.pdf |
VANCOCIN HYDROCHLORIDE
CAPSULE;ORAL; EQ 125MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050606 | ANI PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090439 | LUPIN LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210729 | ORIENT PHARMA CO LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065490 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050606 | ANI PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090439 | LUPIN LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210729 | ORIENT PHARMA CO LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065490 | STRIDES PHARMA |