Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075041
Company: ALKERMES GAINESVILLE
Company: ALKERMES GAINESVILLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | 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 |
---|---|---|---|---|---|---|---|
09/22/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide%20Mononitrate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
09/10/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/22/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75041_Isosorbide%20Mononitrate_prntlbl.pdf |