Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060700
Company: MEDIMETRIKS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEO-SYNALAR FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE 0.025%;EQ 3.5MG BASE/GM CREAM;TOPICAL 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
06/11/1963 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
02/25/2015 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/18/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/18/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/12/1992 SUPPL-15 Labeling

Label is not available on this site.

01/31/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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