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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206128

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NDA 206128 describes METHOCARBAMOL, which is a drug marketed by Hetero Labs Ltd Iii, Mylan Institutional, Watson Labs, Able, Sandoz, Renaissance Ssa Llc, 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, Luitpold Pharms Inc, Stevens J, Par Pharm, and Mcneil, and is included in sixty-four NDAs. It is available from fifty-two 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: 206128

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 206128

Suppliers and Packaging for NDA: 206128

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOCARBAMOL
methocarbamol
SOLUTION;IM-IV 206128 ANDA AuroMedics Pharma LLC 55150-223 55150-223-10 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-223-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IM-IVStrength1GM/10ML (100MG/ML)
Approval Date:May 27, 2016TE:APRLD:No


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