Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT RX USA LLC
STAT RX USA LLC
786036330
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEFAZODONE HYDROCHLORIDE
Product Details
NDC Product Code
16590-166Application Number
ANDA076037Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 7, 2011CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
NefazodoneActive
Code: 27X63J94GRClass: ACTIBQuantity: 100 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT