Drugs@FDA: FDA-Approved Drugs
Company: DEXCEL LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/17/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75522ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-522_Isosorbide%20Mononitrate.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/26/2022 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
10/31/2014 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/29/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
03/24/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
02/19/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/19/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/26/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/04/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/04/2001 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/22/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/08/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
ISOSORBIDE MONONITRATE
TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216557 | AUROBINDO PHARMA |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075155 | CHARTWELL MOLECULAR |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075522 | DEXCEL LTD |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210918 | RICONPHARMA LLC |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214115 | SHANDONG |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200495 | TORRENT PHARMS |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075395 | ZYDUS HLTHCARE |
TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216557 | AUROBINDO PHARMA |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075155 | CHARTWELL MOLECULAR |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075522 | DEXCEL LTD |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210918 | RICONPHARMA LLC |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214115 | SHANDONG |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200270 | TORRENT PHARMS |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075395 | ZYDUS HLTHCARE |