Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006530
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVC SULFANILAMIDE 15% CREAM;VAGINAL Prescription None Yes Yes
AVC SULFANILAMIDE 1.05GM SUPPOSITORY;VAGINAL 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
06/05/1965 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/24/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/18/2013 SUPPL-19 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf
04/19/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/13/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/24/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/27/1987 SUPPL-8 Labeling

Label is not available on this site.

01/27/1987 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/27/1987 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/18/2013 SUPPL-19 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf

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