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Generated: January 23, 2019

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Details for New Drug Application (NDA): 073580

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NDA 073580 describes EMVERM, which is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the EMVERM profile page.

The generic ingredient in EMVERM is mebendazole. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
Summary for 073580
Tradename:EMVERM
Applicant:Impax Labs Inc
Ingredient:mebendazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 073580
Medical Subject Heading (MeSH) Categories for 073580
Suppliers and Packaging for NDA: 073580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMVERM mebendazole TABLET, CHEWABLE;ORAL 073580 ANDA Impax Specialty Pharma 64896-669 64896-669-30 1 BLISTER PACK in 1 CARTON (64896-669-30) > 1 TABLET, CHEWABLE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength100MG
Approval Date:Jan 4, 1995TE:RLD:No

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