Details for New Drug Application (NDA): 206799
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NDA 206799 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Eugia Pharma, Gland Pharma Ltd, Meitheal, Mylan Labs Ltd, Sandoz Inc, Slate Run Pharma, UBI, Xellia Pharms Aps, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-five NDAs. It is available from thirty-two suppliers. Additional details are available on the VORICONAZOLE profile page.
The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
The generic ingredient in VORICONAZOLE is voriconazole. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 206799
| Tradename: | VORICONAZOLE |
| Applicant: | Novel Labs Inc |
| Ingredient: | voriconazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206799
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORICONAZOLE | voriconazole | FOR SUSPENSION;ORAL | 206799 | ANDA | Novel Laboratories, Inc. | 40032-038 | 40032-038-60 | 1 BOTTLE in 1 CARTON (40032-038-60) / 75 mL in 1 BOTTLE (40032-038-00) |
| VORICONAZOLE | voriconazole | FOR SUSPENSION;ORAL | 206799 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-038 | 43386-038-60 | 1 BOTTLE in 1 CARTON (43386-038-60) / 75 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
| Approval Date: | May 31, 2016 | TE: | AB | RLD: | No | ||||
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