Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050803
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VELTIN CLINDAMYCIN PHOSPHATE; TRETINOIN 1.2%;0.025% GEL;TOPICAL Prescription BX Yes 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
07/16/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050803s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050803s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803s000_veltin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/16/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050803s000lbl.pdf

VELTIN

There are no Therapeutic Equivalents.

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