Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060733
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACITRACIN BACITRACIN 10,000 UNITS/VIAL INJECTABLE;INJECTION Prescription None No No
BACITRACIN BACITRACIN 50,000 UNITS/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
07/29/1948 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
05/05/2004 SUPPL-12 Labeling

Label is not available on this site.

04/05/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/2004 SUPPL-9 Labeling

Label is not available on this site.

09/16/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/10/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/08/1994 SUPPL-6 Labeling

Label is not available on this site.

02/20/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

BACITRACIN

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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