Orphenadrine Citrate

Orphenadrine Citrate Extended-Release Tablets

Approved

Approval ID

0f50125a-6d89-4b2b-b48b-daac6129182c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 29, 2010

Manufacturers

FDA

Preferred Pharmaceuticals, Inc

DUNS: 791119022

Products 1

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

NDC Product Code68788-9150

Application NumberANDA040284

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateNovember 20, 2009

Generic NameOrphenadrine Citrate

ORPHENADRINE CITRATEActive

Quantity: 100 mg in 1 1

Code: X0A40N8I4S

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT