Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Beijing Sciecure Pharmaceutical Co., Ltd.
Rhodes Pharmaceuticals L.P.
547707195
Quotient Sciences-Philadelphia, LLC
Rhodes Pharmaceuticals L.P.
126874135
Sciecure Pharma Inc.
Rhodes Pharmaceuticals L.P.
078463813
Products3
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
42858-703Application Number
ANDA209293Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 30, 2023COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5XClass: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 12.5 mg in 1 1
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UMClass: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141JClass: IACT
PAROXETINE
Product Details
NDC Product Code
42858-707Application Number
ANDA209293Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 30, 2023CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 37.5 mg in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141JClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UMClass: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
PAROXETINE
Product Details
NDC Product Code
42858-705Application Number
ANDA209293Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 30, 2023ParoxetineActive
Code: X2ELS050D8Class: ACTIMQuantity: 25 mg in 1 1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141JClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357Class: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UMClass: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT