PAROXETINE
These highlights do not include all the information needed to use PAROXETINE safely and effectively. See full prescribing information for PAROXETINE. PAROXETINE (paroxetine) CAPSULE for ORAL use.Initial U.S. Approval: 1992
Approved
Approval ID
2c5836c3-2099-452e-b6af-d2d50dc359fd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2021
Manufacturers
FDA
Solco Healthcare LLC
DUNS: 828343017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
paroxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-409
Application NumberANDA207188
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2017
FDA Product Classification
INGREDIENTS (10)
PAROXETINE MESYLATEActive
Quantity: 7.5 mg in 1 1
Code: M711N184JE
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT