Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062938
Company: PERRIGO CO TENNESSEE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;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
07/31/1989 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
08/01/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/18/2002 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/18/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

OINTMENT;OPHTHALMIC; 0.1%;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
MAXITROL DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription Yes AT 050065 NOVARTIS
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 064063 BAUSCH AND LOMB
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription No AT 062938 PERRIGO CO TENNESSEE

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