Details for New Drug Application (NDA): 203503
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NDA 203503 describes VORICONAZOLE, which is a drug marketed by Amneal Pharms, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Chartwell Rx, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-six NDAs. It is available from thirty-three 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-five 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-five suppliers are listed for this compound. Additional details are available on the voriconazole profile page.
Summary for 203503
| Tradename: | VORICONAZOLE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | voriconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203503
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VORICONAZOLE | voriconazole | TABLET;ORAL | 203503 | ANDA | American Health Packaging | 60687-273 | 60687-273-21 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-273-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-273-11) |
| VORICONAZOLE | voriconazole | TABLET;ORAL | 203503 | ANDA | American Health Packaging | 60687-294 | 60687-294-21 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-294-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-294-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 2, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 2, 2015 | TE: | AB | RLD: | No | ||||
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