Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
State of Florida DOH Central Pharmacy
State of Florida DOH Central Pharmacy
829348114
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
paroxetine
Product Details
NDC Product Code
53808-0753Application Number
ANDA075356Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 29, 2010ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 30 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
paroxetine
Product Details
NDC Product Code
53808-0750Application Number
ANDA075356Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 29, 2010ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
paroxetine
Product Details
NDC Product Code
53808-0754Application Number
ANDA075356Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 29, 2010ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 40 mg in 1 1
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
paroxetine
Product Details
NDC Product Code
53808-0748Application Number
ANDA075356Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 29, 2010ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 10 mg in 1 1
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT