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Details for New Drug Application (NDA): 204404

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NDA 204404 describes METHOCARBAMOL, which is a drug marketed by Hetero Labs Ltd Iii, Mylan Institutional, Watson Labs, Able, Sandoz, Renaissance Pharma, 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, Atlas Pharms Llc, Upsher Smith, Monterey Pharms Llc, 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-three NDAs. It is available from fifty-five 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: 204404

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 204404

Suppliers and Packaging for NDA: 204404

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOCARBAMOL
methocarbamol
SOLUTION;IM-IV 204404 ANDA General Injectables and Vaccines, Inc. 52584-073 52584-073-00 1 VIAL, SINGLE-DOSE in 1 BAG (52584-073-00) > 10 mL in 1 VIAL, SINGLE-DOSE
METHOCARBAMOL
methocarbamol
SOLUTION;IM-IV 204404 ANDA Mylan Institutional LLC 67457-273 67457-273-10 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-273-10) > 10 mL in 1 VIAL, SINGLE-DOSE (67457-273-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IM-IVStrength1GM/10ML (100MG/ML)
Approval Date:Dec 5, 2014TE:APRLD:No


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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.

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