Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075147
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 20MG | 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 |
---|---|---|---|---|---|---|---|
11/27/1998 | ORIG-1 | Approval |
Label
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.htm https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-147_Isosorbide.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/07/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
03/20/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/23/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |