MedPath
FDA Product

AMITRIPTYLINE HYDROCHLORIDE

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

Basic Information

AMITRIPTYLINE HYDROCHLORIDE

71335-0566

Regulatory Information

71335-0566

ANDA202446

C73584

October 23, 2019

USA

Amitriptyline Hydrochloride Tablets, USP

HUMAN PRESCRIPTION DRUG LABEL

21

Company Information

171714327

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

AMITRIPTYLINE HYDROCHLORIDE

Quantity: 150 mg in 1 1

Code: 26LUD4JO9K

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Active Moieties

AMITRIPTYLINE

Code: 1806D8D52K

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