Details for New Drug Application (NDA): 011792

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 Effect

Centrally-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	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:	RX	Dosage:	TABLET;ORAL			Strength	350MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AA	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Sep 13, 2007	TE:	AB	RLD:	Yes

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