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FDA Product

Morphine Sulfate

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

Basic Information

Morphine Sulfate

51862-186

Regulatory Information

51862-186

ANDA205386

C73584

July 6, 2023

USA

These highlights do not include all the information needed to use Morphine sulfate extended-release tablets safely and effectively. See full prescribing information for Morphine sulfate extended-release tablets. Morphine sulfate extended-release tablets (morphine sulfate extended-release tablets), for oral use CII Initial U.S. Approval: 1941

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

867220261

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

D&C RED NO. 7

Code: ECW0LZ41X8

Class Code: IACT

MORPHINE SULFATE

Quantity: 30 mg in 1 1

Code: X3P646A2J0

Class Code: ACTIB

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

Active Moieties

MORPHINE

Code: 76I7G6D29C

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