Details for New Drug Application (NDA): 219683
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NDA 219683 describes INLEXZO, which is a drug marketed by Janssen Biotech 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 INLEXZO profile page.
The generic ingredient in INLEXZO is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
The generic ingredient in INLEXZO is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 219683
| Tradename: | INLEXZO |
| Applicant: | Janssen Biotech |
| Ingredient: | gemcitabine hydrochloride |
| Patents: | 3 |
Pharmacology for NDA: 219683
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 219683
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INLEXZO | gemcitabine hydrochloride | SYSTEM;INTRAVESICAL | 219683 | NDA | Janssen Biotech, Inc | 57894-225 | 57894-225-01 | 1 SYSTEM in 1 BOX (57894-225-01) |
| INLEXZO | gemcitabine hydrochloride | SYSTEM;INTRAVESICAL | 219683 | NDA | Janssen Biotech, Inc | 57894-225 | 57894-225-99 | 1 SYSTEM in 1 BOX (57894-225-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;INTRAVESICAL | Strength | EQ 225MG BASE | ||||
| Approval Date: | Sep 9, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 9, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 19, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jun 28, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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