Details for New Drug Application (NDA): 021735
✉ Email this page to a colleague
NDA 021735 describes TERCONAZOLE, which is a drug marketed by Fougera Pharms, Fougera Pharms Inc, Taro, and Padagis Israel, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the TERCONAZOLE profile page.
The generic ingredient in TERCONAZOLE 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.
The generic ingredient in TERCONAZOLE 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 021735
| Tradename: | TERCONAZOLE |
| Applicant: | Fougera Pharms Inc |
| Ingredient: | terconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021735
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERCONAZOLE | terconazole | CREAM;VAGINAL | 021735 | NDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0347 | 0168-0347-20 | 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20) |
| TERCONAZOLE | terconazole | CREAM;VAGINAL | 021735 | NDA | A-S Medication Solutions | 50090-6299 | 50090-6299-0 | 20 g in 1 TUBE, WITH APPLICATOR (50090-6299-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | 0.8% | ||||
| Approval Date: | Oct 1, 2004 | TE: | BX | RLD: | Yes | ||||
Complete Access Available with Subscription
