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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 216682

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NDA 216682 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Macleods Pharms Ltd, Novel Labs Inc, Rising, and Rubicon Research, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the CEVIMELINE HYDROCHLORIDE profile page.

The generic ingredient in CEVIMELINE HYDROCHLORIDE is cevimeline hydrochloride. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.

Summary for 216682

Tradename:	CEVIMELINE HYDROCHLORIDE
Applicant:	Rubicon Research
Ingredient:	cevimeline hydrochloride
Patents:	0

Pharmacology for NDA: 216682

Mechanism of Action	Cholinergic Muscarinic Agonists

Suppliers and Packaging for NDA: 216682

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	216682	ANDA	Bryant Ranch Prepack	71335-2326	71335-2326-1	30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-1)
CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	216682	ANDA	Bryant Ranch Prepack	71335-2326	71335-2326-2	60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2326-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Apr 6, 2023	TE:	AB	RLD:	No

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