Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206071
Company: NAVINTA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/24/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206071Orig1s000ltr.pdf

METHOCARBAMOL

SOLUTION;IM-IV; 1GM/10ML (100MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 207496 AM REGENT
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 206128 AUROBINDO PHARMA LTD
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 209331 FRESENIUS KABI USA
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 211504 GLAND PHARMA LTD
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 205354 MONTEREY PHARMS LLC
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 204404 MYLAN INSTITUTIONAL
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 206071 NAVINTA LLC
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 205404 SAGENT PHARMS INC
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 208116 SLATE
METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription No AP 207522 SOMERSET THERAPS LLC
ROBAXIN METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION;IM-IV Prescription Yes AP 011790 HIKMA

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