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The generic ingredient in VERMOX is mebendazole. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
Generic Entry Opportunity Date for 208398
Generic Entry Date for 208398*:
Constraining patent/regulatory exclusivity:
*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: 208398
Profile for product number 001
|Active Rx/OTC/Discontinued:||DISCN||Dosage:||TABLET, CHEWABLE;ORAL||Strength||500MG|
|Approval Date:||Oct 19, 2016||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Oct 19, 2019|
|Regulatory Exclusivity Use:||NEW STRENGTH|
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