Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207522
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS 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 |
---|---|---|---|---|---|---|---|
07/31/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/08/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/08/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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 | EUGIA PHARMA |
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 | 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 RUN PHARMA |
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 |