Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Roxane Laboratories, Inc
833490464
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Mallinckrodt Inc.
H.J. Harkins Company, Inc.
Roxane Laboratories, Inc
163205300
Boehringer Ingelheim Roxane Inc
H.J. Harkins Company, Inc.
Roxane Laboratories, Inc
058839929
Products2
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
52959-182Application Number
NDA022195Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 29, 2011MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Morphine Sulfate
Product Details
NDC Product Code
52959-138Application Number
NDA022195Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 29, 2011STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT