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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060751
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEO-CORTEF HYDROCORTISONE ACETATE; NEOMYCIN SULFATE 0.5%;EQ 3.5MG BASE/GM OINTMENT;TOPICAL Discontinued None No No
NEO-CORTEF HYDROCORTISONE ACETATE; NEOMYCIN SULFATE 1%;EQ 3.5MG BASE/GM OINTMENT;TOPICAL Discontinued None No No
NEO-CORTEF HYDROCORTISONE ACETATE; NEOMYCIN SULFATE 2.5%;EQ 3.5MG BASE/GM OINTMENT;TOPICAL Discontinued None 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
05/18/1965 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
01/22/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/22/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/23/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/04/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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