Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061580
Company: X GEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACI-RX BACITRACIN 5,000,000 UNITS/BOT POWDER;FOR RX COMPOUNDING Discontinued 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
01/06/1972 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
09/25/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/29/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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