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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 011792


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NDA 011792 describes SOMA, which is a drug marketed by Mylan Speciality Lp, Meda Pharms, and Ipsen Pharma, and is included in four NDAs. It is available from two suppliers. Additional details are available on the SOMA profile page.

The generic ingredient in SOMA is lanreotide acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.
Summary for 011792
Tradename:SOMA
Applicant:Mylan Speciality Lp
Ingredient:carisoprodol
Patents:0
Pharmacology for NDA: 011792
Physiological EffectCentrally-mediated Muscle Relaxation
Medical Subject Heading (MeSH) Categories for 011792
Muscle Relaxants, Central
Suppliers and Packaging for NDA: 011792
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOMA carisoprodol CAPSULE;ORAL 011792 NDA Viatris Specialty LLC 0037-2001 0037-2001-01 100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01)
SOMA carisoprodol CAPSULE;ORAL 011792 NDA Viatris Specialty LLC 0037-2250 0037-2250-10 100 TABLET in 1 BOTTLE, PLASTIC (0037-2250-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength350MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Sep 13, 2007TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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