Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050782
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAGEL CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL;TOPICAL Prescription BT 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
11/27/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50782lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50782LTR-LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-782_Clindagel.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/27/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50782lbl.pdf

CLINDAGEL

There are no Therapeutic Equivalents.

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