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FDA Approval

Morphine Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 9, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Morphine(20 mg in 5 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

ATLANTIC BIOLOGICALS CORP.

ATLANTIC BIOLOGICALS CORP.

047437707

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Morphine Sulfate

Product Details

NDC Product Code
17856-0404
Application Number
NDA022195
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 9, 2016
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 5 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
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