Details for New Drug Application (NDA): 212239
NDA 212239 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 eleven suppliers. Additional details are available on the ITRACONAZOLE profile page.
The generic ingredient in ITRACONAZOLE is itraconazole. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
The generic ingredient in ITRACONAZOLE is itraconazole. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 212239
| Tradename: | ITRACONAZOLE |
| Applicant: | Annora Pharma |
| Ingredient: | itraconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212239
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 212239 | ANDA | Camber Pharmaceuticals, Inc. | 31722-006 | 31722-006-31 | 1 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASS |
| ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 212239 | ANDA | Natco Pharma USA LLC | 69339-159 | 69339-159-17 | 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Sep 1, 2020 | TE: | AA | RLD: | No | ||||
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