Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065510
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE;ORAL Prescription AB No No
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE;ORAL Prescription AB 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
04/09/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065510s000ltr.pdf

VANCOMYCIN 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 INC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE;ORAL Prescription No AB 065478 AKORN
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
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE;ORAL Prescription No AB 065510 WATSON LABS

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 INC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065478 AKORN
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
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065510 WATSON LABS

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