Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064028
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC; POLYMYXIN B SULFATE 500 UNITS/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription AT 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
01/30/1995 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
03/10/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/27/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/17/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BACITRACIN ZINC AND POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC; 500 UNITS/GM;10,000 UNITS/GM
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC; POLYMYXIN B SULFATE 500 UNITS/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 064028 AKORN
BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC; POLYMYXIN B SULFATE 500 UNITS/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 064046 BAUSCH AND LOMB
BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC; POLYMYXIN B SULFATE 500 UNITS/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 065022 PERRIGO CO TENNESSEE

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