Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050526
Company: WESTWOOD SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STATICIN ERYTHROMYCIN 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;TOPICAL Discontinued None Yes No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
06/03/1980 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
12/15/2002 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50526slr010_Staticin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50526slr010ltr.pdf
03/13/1995 SUPPL-9 Labeling

Label is not available on this site.

03/24/1982 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/02/1981 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/02/1981 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/14/1981 SUPPL-5 Labeling

Label is not available on this site.

06/12/1980 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/12/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/10/1986 SUPPL-2 Labeling

Label is not available on this site.

12/23/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/15/2002 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50526slr010_Staticin_lbl.pdf

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