Details for New Drug Application (NDA): 208591
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NDA 208591 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 208591
| Tradename: | ITRACONAZOLE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | itraconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208591
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 208591 | ANDA | NorthStar RxLLC | 16714-743 | 16714-743-01 | 7 BLISTER PACK in 1 CARTON (16714-743-01) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK |
| ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 208591 | ANDA | NorthStar RxLLC | 16714-743 | 16714-743-02 | 30 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-743-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 12, 2017 | TE: | AB | RLD: | No | ||||
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