Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062166
Company: PERRIGO CO TENNESSEE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT;OPHTHALMIC Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/14/1981 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
09/12/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/07/1993 SUPPL-10 Labeling

Label is not available on this site.

12/09/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/18/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/17/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/17/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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