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Details for New Drug Application (NDA): 011792

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NDA 011792 describes SOMA, which is a drug marketed by Meda Pharms, Ipsen Pharma, and Pharmacia And Upjohn, and is included in five NDAs. It is available from five suppliers. There are three patents 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 NDA: 011792

Meda Pharms
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 011792

Suppliers and Packaging for NDA: 011792

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 011792 NDA Meda Pharmaceuticals Inc. 0037-2001 0037-2001-01 100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01)
CAPSULE;ORAL 011792 NDA Meda Pharmaceuticals Inc. 0037-2250 0037-2250-04 4 POUCH in 1 BOX (0037-2250-04) > 1 TABLET in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength350MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.