Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PAXIL
Product Details
NDC Product Code
54868-3526Application Number
NDA020031Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 5, 2012ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 30 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PAXIL
Product Details
NDC Product Code
54868-2976Application Number
NDA020031Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 5, 2012ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 20 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT