Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Somerset Therapeutics, LLC
079947873
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Somerset Therapeutics Limited
Somerset Therapeutics, LLC
Somerset Therapeutics, LLC
677236695
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methocarbamol
Product Details
NDC Product Code
70069-101Application Number
ANDA207522Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
December 18, 2023SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
MethocarbamolActive
Code: 125OD7737XClass: ACTIBQuantity: 100 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQClass: IACTQuantity: 0.5 mL in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT