Details for New Drug Application (NDA): 076712
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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 076712
Tradename: | TERCONAZOLE |
Applicant: | Fougera Pharms |
Ingredient: | terconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 076712
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERCONAZOLE | terconazole | CREAM;VAGINAL | 076712 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0346 | 0168-0346-46 | 45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46) |
TERCONAZOLE | terconazole | CREAM;VAGINAL | 076712 | ANDA | A-S Medication Solutions | 50090-6266 | 50090-6266-0 | 45 g in 1 TUBE, WITH APPLICATOR (50090-6266-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | 0.4% | ||||
Approval Date: | Feb 18, 2005 | TE: | AB | RLD: | No |
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