Details for New Drug Application (NDA): 206741
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NDA 206741 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 fifteen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 206741
| Tradename: | ITRACONAZOLE |
| Applicant: | Alembic |
| Ingredient: | itraconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206741
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 206741 | ANDA | Alembic Pharmaceuticals Limited | 46708-204 | 46708-204-04 | 28 CAPSULE in 1 CARTON (46708-204-04) |
| ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 206741 | ANDA | Alembic Pharmaceuticals Limited | 46708-204 | 46708-204-10 | 100 CAPSULE in 1 CARTON (46708-204-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 13, 2016 | TE: | AB | RLD: | No | ||||
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