Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Pharmaceutical Associates, Inc.
097630693
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Entreprises Importfab, Inc.
Pharmaceutical Associates, Inc.
Pharmaceutical Associates, Inc.
248586117
Pharmaceutical Associates, Inc.
Pharmaceutical Associates, Inc.
Pharmaceutical Associates, Inc.
097630693
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naprosyn
Product Details
NDC Product Code
0121-1798Application Number
NDA018965Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 16, 2020ORANGEInactive
Code: 5EVU04N5QUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
PINEAPPLEInactive
Code: 2A88ZO081OClass: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 250 mg in 10 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Naprosyn
Product Details
NDC Product Code
0121-2697Application Number
NDA018965Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 16, 2020SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
PINEAPPLEInactive
Code: 2A88ZO081OClass: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 20 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
Naprosyn
Product Details
NDC Product Code
0121-0899Application Number
NDA018965Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 16, 2020SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
PINEAPPLEInactive
Code: 2A88ZO081OClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 125 mg in 5 mL