Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077149
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERCONAZOLE TERCONAZOLE 80MG SUPPOSITORY;VAGINAL Prescription AB No 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
03/17/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077149ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/20/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

TERCONAZOLE

SUPPOSITORY;VAGINAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TERCONAZOLE TERCONAZOLE 80MG SUPPOSITORY;VAGINAL Prescription No AB 077149 PERRIGO ISRAEL
TERCONAZOLE TERCONAZOLE 80MG SUPPOSITORY;VAGINAL Prescription No AB 077553 TARO

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