paroxetine
PAROXETINE TABLETS USP 10 mg, 20 mg, 30 mg and 40 mg
Approved
Approval ID
c9b57101-2455-463d-b8d7-b2316cecd67a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 29, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PAROXETINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0753
Application NumberANDA075356
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2010
FDA Product Classification
INGREDIENTS (8)
PAROXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PAROXETINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0750
Application NumberANDA075356
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2010
FDA Product Classification
INGREDIENTS (8)
PAROXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PAROXETINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0754
Application NumberANDA075356
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2010
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
PAROXETINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0748
Application NumberANDA075356
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2010
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT