Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078995
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG 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 |
|---|---|---|---|---|---|---|---|
| 03/19/2012 | ORIG-1 | Approval |
Review (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078995Orig1s000OtherActionLtrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078995Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2015 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |