Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040486
Company: MOUNTAIN
Company: MOUNTAIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METAXALONE | METAXALONE | 400MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/27/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/040486Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
METAXALONE
TABLET;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METAXALONE | METAXALONE | 400MG | TABLET;ORAL | Prescription | No | AB | 040486 | MOUNTAIN |
METAXALONE | METAXALONE | 400MG | TABLET;ORAL | Prescription | No | AB | 207466 | SCIEGEN PHARMS INC |