MedPath
FDA Product

Amantadine Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amantadine Hydrochloride

62135-609

Regulatory Information

62135-609

ANDA209171

C73584

June 26, 2023

USA

Amantadine Hydrochloride Capsules, USP Rx only

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Chartwell RX, LLC

079394054

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

AMANTADINE HYDROCHLORIDE

Quantity: 100 mg in 1 1

Code: M6Q1EO9TD0

Class Code: ACTIB

Active Moieties

AMANTADINE

Code: BF4C9Z1J53

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