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Generated: October 21, 2018

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Details for New Drug Application (NDA): 077699

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NDA 077699 describes MEFLOQUINE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma Intl Pharms, Sandoz, Us Army Walter Reed, and West-ward Pharms Int, and is included in five NDAs. It is available from six suppliers. Additional details are available on the MEFLOQUINE HYDROCHLORIDE profile page.

The generic ingredient in MEFLOQUINE HYDROCHLORIDE is mefloquine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mefloquine hydrochloride profile page.
Summary for 077699
Applicant:Hikma Intl Pharms
Ingredient:mefloquine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 077699
Medical Subject Heading (MeSH) Categories for 077699
Suppliers and Packaging for NDA: 077699
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEFLOQUINE HYDROCHLORIDE mefloquine hydrochloride TABLET;ORAL 077699 ANDA West-Ward Pharmaceuticals Corp 0143-1282 0143-1282-22 25 TABLET in 1 BOTTLE (0143-1282-22)
MEFLOQUINE HYDROCHLORIDE mefloquine hydrochloride TABLET;ORAL 077699 ANDA Rebel Distributors Corp 21695-561 21695-561-10 10 TABLET in 1 BOTTLE (21695-561-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Apr 21, 2010TE:RLD:No

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