Details for New Drug Application (NDA): 219293
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NDA 219293 describes DANZITEN, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DANZITEN profile page.
The generic ingredient in DANZITEN is nilotinib tartrate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib tartrate profile page.
The generic ingredient in DANZITEN is nilotinib tartrate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib tartrate profile page.
Summary for 219293
| Tradename: | DANZITEN |
| Applicant: | Azurity |
| Ingredient: | nilotinib tartrate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219293
Generic Entry Date for 219293*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 219293
Suppliers and Packaging for NDA: 219293
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DANZITEN | nilotinib tartrate | TABLET;ORAL | 219293 | NDA | Azurity Pharmaceuticals, Inc. | 24338-154 | 24338-154-01 | 4 CARTON in 1 CARTON (24338-154-01) / 2 BLISTER PACK in 1 CARTON (24338-154-02) / 14 TABLET in 1 BLISTER PACK (24338-154-03) |
| DANZITEN | nilotinib tartrate | TABLET;ORAL | 219293 | NDA | Azurity Pharmaceuticals, Inc. | 24338-155 | 24338-155-01 | 4 CARTON in 1 CARTON (24338-155-01) / 2 BLISTER PACK in 1 CARTON (24338-155-02) / 14 TABLET in 1 BLISTER PACK (24338-155-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 71MG BASE | ||||
| Approval Date: | Nov 7, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 18, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 18, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 18, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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