Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075915
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIOCONAZOLE TIOCONAZOLE 6.5% OINTMENT;VAGINAL Over-the-counter 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
11/21/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75915.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075915.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2015 SUPPL-25 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/30/2007 SUPPL-15 Labeling

Label is not available on this site.

10/10/2003 SUPPL-6 Labeling

Label is not available on this site.

12/09/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

TIOCONAZOLE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

OINTMENT;VAGINAL; 6.5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
TIOCONAZOLE TIOCONAZOLE 6.5% OINTMENT;VAGINAL Over-the-counter No 075915 PERRIGO
VAGISTAT-1 TIOCONAZOLE 6.5% OINTMENT;VAGINAL Over-the-counter Yes 020676 COMBE

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