Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061667
Company: ANI PHARMS INC
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 None 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
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
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.

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