MedPath
FDA Product

Amitriptyline Hydrochloride

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

Basic Information

Amitriptyline Hydrochloride

16714-448

Regulatory Information

16714-448

ANDA085968

C73584

August 13, 2020

USA

Amitriptyline Hydrochloride Tablets, USP

HUMAN PRESCRIPTION DRUG LABEL

16

Company Information

Northstar RxLLC

830546433

Active Ingredients

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

AMITRIPTYLINE HYDROCHLORIDE

Quantity: 50 mg in 1 1

Code: 26LUD4JO9K

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

AMITRIPTYLINE

Code: 1806D8D52K

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