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The generic ingredient in HYLENEX RECOMBINANT is hyaluronidase recombinant human. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hyaluronidase recombinant human profile page.
Generic Entry Opportunity Date for 021859
*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: 021859
Suppliers and Packaging for NDA: 021859
|Tradename||Generic Name||Dosage||NDA||Application Type||Supplier||National Drug Code||Package Code||Package|
|HYLENEX RECOMBINANT||hyaluronidase recombinant human||INJECTABLE;INJECTION||021859||NDA||Halozyme, Inc.||18657-117||18657-117-04||4 BOX in 1 CARTON (18657-117-04) > 1 VIAL in 1 BOX (18657-117-02) > 1 mL in 1 VIAL (18657-117-01)|
Profile for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||INJECTABLE;INJECTION||Strength||150 UNITS/ML|
|Approval Date:||Dec 2, 2005||TE:||RLD:||Yes|
|Patent:||➤ Try a Free Trial||Patent Expiration:||Sep 23, 2027||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
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