Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060764
Company: PERRIGO CO TENNESSEE
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
01/22/1981 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
08/18/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/30/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/19/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/05/1994 SUPPL-6 Labeling

Label is not available on this site.

03/17/1989 SUPPL-4 Manufacturing (CMC)

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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