Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061212
Company: PERRIGO CO TENNESSEE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACITRACIN BACITRACIN 500 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
11/09/1971 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
05/01/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/31/2002 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/07/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 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.

06/12/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/24/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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