Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 063076
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
12/21/1990 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
05/22/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063076s025lbl.pdf
11/30/2011 SUPPL-18 Labeling

Label is not available on this site.

07/25/2005 SUPPL-10 Labeling

Label is not available on this site.

10/04/2002 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/01/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/2001 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/09/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/18/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/25/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/22/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063076s025lbl.pdf

VANCOMYCIN HYDROCHLORIDE

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 AUROBINDO PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202274 EMCURE PHARMS LTD
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 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 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 201048 SANDOZ INC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204125 XELLIA PHARMS APS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English