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Generated: April 18, 2019

DrugPatentWatch Database Preview

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, Ipsen Pharma, and Pharmacia And Upjohn, and is included in five NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the SOMA profile page.

The generic ingredient in SOMA is pegvisomant. One supplier is listed for this compound. Additional details are available on the pegvisomant 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 0037-2001 0037-2001-01 100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01)
SOMA carisoprodol CAPSULE;ORAL 011792 NDA Meda Pharmaceuticals 0037-2250 0037-2250-04 4 POUCH in 1 BOX (0037-2250-04) > 1 TABLET in 1 POUCH

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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