Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040009
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 12/30/1998 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-009_Isosorbide%20Dinitrate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-009_Isosorbide.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/19/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/07/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/23/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |