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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050606
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
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