Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075448
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
| 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 |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/19/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75448ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/10/2007 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/10/2007 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/10/2007 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/14/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/07/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |