Details for New Drug Application (NDA): 205573
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NDA 205573 describes ITRACONAZOLE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Rising, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Annora Pharma, and Apotex, and is included in fourteen NDAs. It is available from fourteen suppliers. Additional details are available on the ITRACONAZOLE profile page.
The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 205573
| Tradename: | ITRACONAZOLE |
| Applicant: | Amneal Pharms |
| Ingredient: | itraconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205573
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 205573 | ANDA | Amneal Pharmaceuticals LLC | 65162-087 | 65162-087-34 | 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13) |
| ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 205573 | ANDA | Amneal Pharmaceuticals LLC | 65162-087 | 65162-087-74 | 150 mL in 1 BOTTLE, GLASS (65162-087-74) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Oct 30, 2015 | TE: | AA | RLD: | No | ||||
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