Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Solco Healthcare LLC
828343017
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zhejiang Huahai Pharmaceutical Co., LTD
Solco Healthcare LLC
Solco Healthcare LLC
530732460
Products1
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
43547-409Application Number
ANDA207188Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2017ParoxetineActive
Code: M711N184JEClass: ACTIMQuantity: 7.5 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT