FDA
Cevimeline Hydrochloride
The FDA lists this product in 9 strengths and forms.
Composition
- Active ingredients
- CEVIMELINE HYDROCHLORIDE 30MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA215056-001 · Prescription
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA203775-001 · Prescription
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA204746-001 · Prescription
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleThis page
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA091591-001 · Prescription
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA206808-001 · Prescription
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA218290-001 · Prescription
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA216682-001 · Prescription
- CEVIMELINE HYDROCHLORIDE 30MG · CapsuleANDA091260-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA220267.
At a glance
- Brand name
- Cevimeline Hydrochloride
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Zydus Lifesciences
- Status
- Prescription
- FDA approval
- 11 Mar 2026
- Application
- ANDA220267-001