Last Updated: May 10, 2026

Details for New Drug Application (NDA): 208116

✉ Email this page to a colleague

« Back to Dashboard

NDA 208116 describes METHOCARBAMOL, which is a drug marketed by Dr Reddys, Marsam Pharms Llc, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Monterey Pharms Llc, Navinta Llc, Pharmobedient, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Able, Aiping Pharm Inc, Am Therap, Ani Pharms, Ascot, Aurobindo Pharma Ltd, Bostal, Chartwell Molecular, Clonmel Hlthcare, Dbl Pharms, Granules, Heather, Hetero Labs Ltd Iii, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Kv Pharm, Mikart, Mylan, Nylos, Oxford Pharms, Pioneer Pharms, Pointview Hldings, Prinston Inc, Puracap Pharm, Purepac Pharm, Regcon Holdings, Roxane, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tablicaps, Upsher Smith, Watson Labs, Mcneil, Par Pharm, and Stevens J, and is included in seventy-four NDAs. It is available from sixty-two 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. Additional details are available on the aspirin; methocarbamol profile page.

Summary for 208116

Tradename:	METHOCARBAMOL
Applicant:	Slate Run Pharma
Ingredient:	methocarbamol
Patents:	0

Pharmacology for NDA: 208116

Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 208116

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 208116

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHOCARBAMOL	methocarbamol	SOLUTION;IM-IV	208116	ANDA	Slate Run Pharmaceuticals, LLC	70436-149	70436-149-55	25 VIAL, SINGLE-DOSE in 1 CARTON (70436-149-55) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-149-33)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;IM-IV			Strength	1GM/10ML (100MG/ML)
Approval Date:	Jan 19, 2017	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.