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FDA Approval

Cevimeline Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 19, 2023
Labeling Type
Human Prescription Drug Label
Cevimeline(30 mg in 1 1)

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
59651-422
Application Number
ANDA215056
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 2, 2022
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
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Cevimeline Hydrochloride - FDA Approval | MedPath