Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064153
Company: X GEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACIIM BACITRACIN 50,000 UNITS/VIAL INJECTABLE;INJECTION Prescription AP 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
05/09/1997 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
10/15/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/2002 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/01/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

08/07/2002 SUPPL-3 Labeling

Label is not available on this site.

08/07/2002 SUPPL-2 Labeling

Label is not available on this site.

BACIIM

INJECTABLE;INJECTION; 50,000 UNITS/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACIIM BACITRACIN 50,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 064153 X GEN PHARMS
BACITRACIN BACITRACIN 50,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 206719 AKORN
BACITRACIN BACITRACIN 50,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065116 FRESENIUS KABI USA
BACITRACIN BACITRACIN 50,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 060733 PHARMACIA AND UPJOHN
BACITRACIN BACITRACIN 50,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 090211 SAGENT STRIDES
BACITRACIN BACITRACIN 50,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 203177 XELLIA PHARMS APS

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