Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065088
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/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
02/06/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65010ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/10/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

OINTMENT;OPHTHALMIC; 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 065088 AKORN
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 064064 BAUSCH AND LOMB
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 060764 PERRIGO CO TENNESSEE
NEOSPORIN BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription Yes AT 050417 CASPER PHARMA LLC

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