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Details for New Drug Application (NDA): 091591

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NDA 091591 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Pack Pharms Llc and Roxane and is included in two NDAs. It is available from four 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. Nine suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.

Summary for NDA: 091591

cevimeline hydrochloride
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091591

Suppliers and Packaging for NDA: 091591

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cevimeline hydrochloride
CAPSULE;ORAL 091591 ANDA Roxane Laboratories, Inc. 0054-0334 0054-0334-25 100 CAPSULE in 1 BOTTLE (0054-0334-25)
cevimeline hydrochloride
CAPSULE;ORAL 091591 ANDA Avera McKennan Hospital 69189-0399 69189-0399-1 1 CAPSULE in 1 DOSE PACK (69189-0399-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jul 8, 2013TE:ABRLD:No

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