MedPath
FDA Product

ESOMEPRAZOLE MAGNESIUM D/R

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

Basic Information

ESOMEPRAZOLE MAGNESIUM D/R

61919-834

Regulatory Information

61919-834

ANDA078279

C73584

October 20, 2015

USA

ESOMEPRAZOLE MAGNESIUM

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

DirectRX

079254320

Active Ingredients

D&C Red No. 28

Code: 767IP0Y5NH

Class Code: IACT

Gelatin

Code: 2G86QN327L

Class Code: IACT

Ammonia

Code: 5138Q19F1X

Class Code: IACT

Potassium Hydroxide

Code: WZH3C48M4T

Class Code: IACT

Propylene Glycol

Code: 6DC9Q167V3

Class Code: IACT

Isopropyl Alcohol

Code: ND2M416302

Class Code: IACT

Shellac

Code: 46N107B71O

Class Code: IACT

Esomeprazole Magnesium

Quantity: 40 mg in 1 1

Code: R6DXU4WAY9

Class Code: ACTIM

Glyceryl Monostearate

Code: 230OU9XXE4

Class Code: IACT

Hypromelloses

Code: 3NXW29V3WO

Class Code: IACT

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Methacrylic Acid

Code: 1CS02G8656

Class Code: IACT

Polysorbate 80

Code: 6OZP39ZG8H

Class Code: IACT

Talc

Code: 7SEV7J4R1U

Class Code: IACT

Triethyl Citrate

Code: 8Z96QXD6UM

Class Code: IACT

Fd&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

Titanium Dioxide

Code: 15FIX9V2JP

Class Code: IACT

Ferrosoferric Oxide

Code: XM0M87F357

Class Code: IACT

Butyl Alcohol

Code: 8PJ61P6TS3

Class Code: IACT

Alcohol

Code: 3K9958V90M

Class Code: IACT

Hydroxypropyl Cellulose (Type H)

Code: RFW2ET671P

Class Code: IACT

Active Moieties

ESOMEPRAZOLE

Code: N3PA6559FT

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