Details for New Drug Application (NDA): 203640
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NDA 203640 describes NILOTINIB HYDROCHLORIDE, which is a drug marketed by Apotex and is included in one NDA. It is available from one supplier. Additional details are available on the NILOTINIB HYDROCHLORIDE profile page.
The generic ingredient in NILOTINIB HYDROCHLORIDE is nilotinib hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.
The generic ingredient in NILOTINIB HYDROCHLORIDE is nilotinib hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.
Summary for 203640
| Tradename: | NILOTINIB HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | nilotinib hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203640
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640 | ANDA | Apotex Corp. | 60505-3801 | 60505-3801-0 | 2 BLISTER PACK in 1 CARTON (60505-3801-0) / 14 CAPSULE in 1 BLISTER PACK |
| NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640 | ANDA | Apotex Corp. | 60505-3801 | 60505-3801-2 | 4 CARTON in 1 CARTON (60505-3801-2) / 2 BLISTER PACK in 1 CARTON (60505-3801-3) / 14 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jan 5, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 19, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jan 5, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 19, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jan 5, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 19, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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