Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050584
Company: DOW PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKNE-MYCIN ERYTHROMYCIN 2% OINTMENT;TOPICAL Discontinued None Yes 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
01/10/1985 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/22/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1995 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/14/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/23/1985 SUPPL-1 Labeling

Label is not available on this site.

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