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Last Updated: October 21, 2021

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Details for New Drug Application (NDA): 208507

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NDA 208507 describes METHOCARBAMOL, which is a drug marketed by Dr Reddys, Marsam Pharms Llc, Am Regent, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Monterey Pharms Llc, Mylan Institutional, Navinta Llc, Sagent Pharms Inc, Slate, Somerset Theraps Llc, Able, Am Therap, Ani Pharms, Ascot, Austarpharma Llc, Beximco Pharms Usa, Clonmel Hlthcare, Dbl Pharms, Fosun Pharma, Granules, Heather, Hetero Labs Ltd Iii, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, MLV, Mylan, Nylos, Oxford Pharms, Pioneer Pharms, Prinston Inc, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tablicaps, Upsher Smith, Watson Labs, Mcneil, Par Pharm, and Stevens J, and is included in seventy-three NDAs. It is available from fifty-six suppliers. Additional details are available on the METHOCARBAMOL profile page.

The generic ingredient in METHOCARBAMOL is aspirin; methocarbamol. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; methocarbamol profile page.
Summary for 208507
Applicant:Beximco Pharms Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 208507
Medical Subject Heading (MeSH) Categories for 208507
Suppliers and Packaging for NDA: 208507
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOCARBAMOL methocarbamol TABLET;ORAL 208507 ANDA Marlex Pharmaceuticals Inc 10135-664 10135-664-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-664-01)
METHOCARBAMOL methocarbamol TABLET;ORAL 208507 ANDA Marlex Pharmaceuticals Inc 10135-664 10135-664-05 500 TABLET, FILM COATED in 1 BOTTLE (10135-664-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 21, 2017TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jul 21, 2017TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim

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