Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076747
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | EQ 2MG BASE | TABLET;ORAL | Discontinued | None | No | No |
ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | EQ 4MG BASE | TABLET;ORAL | Discontinued | None | No | No |
ROSIGLITAZONE MALEATE | ROSIGLITAZONE MALEATE | EQ 8MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
01/25/2013 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076747Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076747Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/07/2014 | SUPPL-1 | REMS-Modified |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/25/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076747Orig1s000lbl.pdf |