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Generated: November 12, 2018

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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 three suppliers. 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. Five suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
Summary for 073580
Applicant:Impax Labs Inc
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 Amedra Pharmaceuticals LLC 52054-107 52054-107-01 1 BLISTER PACK in 1 CARTON (52054-107-01) > 1 TABLET, CHEWABLE in 1 BLISTER PACK
EMVERM mebendazole TABLET, CHEWABLE;ORAL 073580 ANDA Bryant Ranch Prepack 63629-1528 63629-1528-1 2 TABLET, CHEWABLE in 1 BOTTLE (63629-1528-1)

Profile for product number 001

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

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