Amantadine Hydrochloride
Approved
Approval ID
14452da8-3b48-497d-9017-bdfb967b7f56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amantadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3216
Application NumberANDA075060
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amantadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2010
FDA Product Classification
INGREDIENTS (9)
AMANTADINE HYDROCHLORIDEActive
Quantity: 50 mg in 5 mL
Code: M6Q1EO9TD0
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT