Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074865
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
04/13/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/27/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/13/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf |