Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077149
Company: PADAGIS ISRAEL

Products on ANDA 077149

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERCONAZOLE	TERCONAZOLE	80MG	SUPPOSITORY;VAGINAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077149

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.

Therapeutic Equivalents for ANDA 077149

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	PADAGIS ISRAEL
TERCONAZOLE	TERCONAZOLE	80MG	SUPPOSITORY;VAGINAL	Prescription	No	AB	077553	TARO