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FDA Product

Morphine Sulfate

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

Basic Information

Morphine Sulfate

70166-101

Regulatory Information

70166-101

NDA201517

C73594

June 12, 2018

USA

These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, CII Initial U.S. Approval: 1941

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Lohxa

079872715

Active Ingredients

MORPHINE SULFATE

Quantity: 100 mg in 5 mL

Code: X3P646A2J0

Class Code: ACTIB

Inactive Ingredients

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

FD&C GREEN NO. 3

Code: 3P3ONR6O1S

Class Code: IACT

Active Moieties

MORPHINE

Code: 76I7G6D29C

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