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Details for New Drug Application (NDA): 090200

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NDA 090200 describes METHOCARBAMOL, which is a drug marketed by Hetero Labs Ltd Iii, Mylan Institutional, Watson Labs, Able, Sandoz, Am Therap, Purepac Pharm, Hikma Intl Pharms, Mylan, Heather, Impax Labs, Aurobindo Pharma Ltd, Pioneer Pharms, Puracap Pharm, Nylos, Inwood Labs, Roxane, Tablicaps, Ivax Sub Teva Pharms, Solvay, Marsam Pharms Llc, Upsher Smith, Lannett Holdings Inc, Austarpharma Llc, Kv Pharm, Ascot, Clonmel Hlthcare, Sun Pharm Inds, Prinston Inc, Superpharm, Vintage Pharms, Stevens J, Par Pharm, and Mcneil, and is included in sixty NDAs. It is available from fifty-three suppliers. Additional details are available on the METHOCARBAMOL profile page.

The generic ingredient in METHOCARBAMOL is aspirin; methocarbamol. There are twenty-one drug master file entries for this compound. Additional details are available on the aspirin; methocarbamol profile page.

Summary for NDA: 090200

Hetero Labs Ltd Iii
Therapeutic Class:Skeletal Muscle Relaxants

Pharmacology for NDA: 090200

Suppliers and Packaging for NDA: 090200

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 090200 ANDA KAISER FOUNDATION HOSPITALS 0179-0092 0179-0092-30 30 TABLET in 1 BOTTLE (0179-0092-30)
TABLET;ORAL 090200 ANDA KAISER FOUNDATION HOSPITALS 0179-0092 0179-0092-50 50 TABLET in 1 BOTTLE (0179-0092-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 6, 2009TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Nov 6, 2009TE:AARLD:No

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