Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077149
Company: PADAGIS ISRAEL
Company: PADAGIS 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 | PADAGIS ISRAEL |
TERCONAZOLE | TERCONAZOLE | 80MG | SUPPOSITORY;VAGINAL | Prescription | No | AB | 077553 | TARO |