Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063000
Company: X GEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/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
09/30/1994 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
11/13/2001 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/24/1999 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

01/16/1998 SUPPL-5 Labeling

Label is not available on this site.

01/16/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/20/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/01/1995 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

POLYMYXIN B SULFATE

INJECTABLE;INJECTION; EQ 500,000 UNITS BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206589 AUROBINDO PHARMA LTD
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065372 FRESENIUS KABI USA
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207322 GLAND PHARMA LTD
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090110 MYLAN ASI
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 060716 WEST-WARD PHARMS INT
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 063000 X GEN PHARMS
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202766 XELLIA PHARMS APS

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