Details for New Drug Application (NDA): 019964
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The generic ingredient in TERAZOL 3 is terconazole. There are six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the terconazole profile page.
Summary for 019964
Tradename: | TERAZOL 3 |
Applicant: | Janssen Pharms |
Ingredient: | terconazole |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;VAGINAL | Strength | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 21, 1991 | TE: | RLD: | Yes |
Expired US Patents for NDA 019964
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | TERAZOL 3 | terconazole | CREAM;VAGINAL | 019964-001 | Feb 21, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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