Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
APL HEALTHCARE LIMITED
Aurobindo Pharma Limited
650844777
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cevimeline Hydrochloride
Product Details
NDC Product Code
59651-422Application Number
ANDA215056Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 2, 2022CevimelineActive
Code: P81Q6V85NPClass: ACTIRQuantity: 30 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT