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Last Updated: May 29, 2024

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. Two suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.
Summary for 011792
Applicant:Mylan Speciality Lp
Formulation / Manufacturing:see details
Pharmacology for NDA: 011792
Medical Subject Heading (MeSH) Categories for 011792
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 Meda Pharmaceuticals Inc. 0037-2001 0037-2001-01 100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01)
SOMA carisoprodol CAPSULE;ORAL 011792 NDA Meda Pharmaceuticals Inc. 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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