Last Updated: May 3, 2026

Details for New Drug Application (NDA): 215056

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NDA 215056 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Macleods Pharms Ltd, Novel Labs Inc, Rising, Rubicon Research, and Zydus Lifesciences, and is included in nine NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.

Summary for 215056

Tradename:	CEVIMELINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma
Ingredient:	cevimeline hydrochloride
Patents:	0

Pharmacology for NDA: 215056

Mechanism of Action	Cholinergic Muscarinic Agonists

Suppliers and Packaging for NDA: 215056

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	215056	ANDA	Aurobindo Pharma Limited	59651-422	59651-422-01	100 CAPSULE in 1 BOTTLE (59651-422-01)
CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	215056	ANDA	Aurobindo Pharma Limited	59651-422	59651-422-05	500 CAPSULE in 1 BOTTLE (59651-422-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Apr 18, 2023	TE:	AB	RLD:	No

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