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Mefloquine Hydrochloride

Mefloquine Hydrochloride TabletsRev. 07/11

Approved
Approval ID

b6ccbb82-3804-4f02-bf17-f07e22a8b02a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 9, 2012

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Mefloquine Hydrochloride

PRODUCT DETAILS

NDC Product Code21695-561
Application NumberANDA077699
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 5, 2011
Generic NameMefloquine Hydrochloride

INGREDIENTS (10)

MEFLOQUINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 5Y9L3636O3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

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Mefloquine Hydrochloride - FDA Drug Approval Details